NA 700351Recalls & reported problems
Stryker GmbH · Drill Bit AO Fitting · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04546540413758), received between Oct 21, 2016 and Jan 7, 2026 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Detachment Of Device Component2
- Difficult to Remove1
- Fracture1
- Noise, Audible1
Patient problems
- Device Embedded In Tissue or Plaque2
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJan 7, 2026Fracture
AS REPORTED: "DRILL BROKE DURING SURGERY AND REMAINED IN THE PATIENT."
Patient problems: Foreign Body In Patient
MAUDE report 23991433 ↗MalfunctionApr 27, 2022Difficult to Remove; Noise, Audible; Difficult to Remove; Noise, Audible
AS REPORTED: "DIFFICULT TO REMOVE DRILL. ABNORMAL NOISE. PRESUMABLY NOTICED AFTER SURGERY."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14219268 ↗MalfunctionOct 21, 2016Break; Detachment Of Device Component
IT WAS REPORTED VIA FDA SUS VOLUNTARY EVENT REPORT, MW5064572. DURING OPERATIVE PROCEDURE, TWO 2.5MM DRILL BIT TIPS BROKE OFF IN THE ILIAC WING DURING DRILL REMOVAL. UNABLE TO RETRIEVE DRILL TIPS.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 6048532 ↗MalfunctionOct 21, 2016Break; Detachment Of Device Component
IT WAS REPORTED VIA FDA SUS VOLUNTARY EVENT REPORT, MW5064572. DURING OPERATIVE PROCEDURE, TWO 2.5MM DRILL BIT TIPS BROKE OFF IN THE ILIAC WING DURING DRILL REMOVAL. UNABLE TO RETRIEVE DRILL TIPS.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 6048327 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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