Bit, Surgical
Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.
OpenFDA device adverse-event casebook.
FDA Class I (lowest regulatory risk tier, general controls), regulated under 21 CFR §878.4820 (General, Plastic Surgery panel).
FDA MAUDE casebook
openFDA event book Bit, Surgical LIGHT-BOOK · MAUDE
#782 of 1000 · 683 reports · 2002–2026
- BOOK 683 reports
- RANK #782 of 1000
- DEATH 0 death-typed
- INJ 127 injury-typed
- MALF 552 malfunction
- SPAN 2002–2026
- PEAK 2025: 110
- PHOTO Needle, Dental
Nearest event-volume peer: Needle, Dental (1 report gap)
Bit, Surgical sits #782 of 1000 among tracked device types with 683 MAUDE reports spanning 2002–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →
Malfunction reports run above the device-type norm
Bit, Surgical carries 80.8% MALFUNCTION-coded reports, 16.0pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
- INJ 18.6% corpus 30.3% · below corpus mean (-11.7 pp)
- MALF 80.8% corpus 64.8% · above corpus mean (+16.0 pp)
Lead product-problem code Break is 47% of coded problems · Lead manufacturer SMITH & NEPHEW, INC. accounts for 45% of manufacturer-tagged reports · Top event location is 69% of location-tagged rows .
Bit, Surgical in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Bit, Surgical (this)
Bit, Surgical
683 reports
- Needle, Dental
Needle, Dental
682 reports
- Stimulator
Stimulator, Muscle, Powered
678 reports
- Tube
Tube, Drainage, Suprapubic
677 reports
- Forceps
Forceps, General & Plastic Surgery
673 reports
- Hearing Aid
Hearing Aid, Air-Conduction, Prescription
673 reports
What this shows Bit, Surgical carries 683 MAUDE reports, ranked #782 of 1000.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Top Product Problems
Yearly Trend
Reports rose to 110 in 2025, up from an average of 66 in the two years before - a recent-year increase, not a lifetime pattern.
Related Entities for Bit, Surgical
Top Manufacturers
Event Locations
Nationwide devices with a comparable report-volume footprint
Bit, Surgical carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.
Similar report volume
Nearest other device types by FDA MAUDE report count (683 here).
Similar death-typed counts
Nearest other device types by death-typed report count (0 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Bit, Surgical are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.
Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Bit, Surgical; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.