NA 1320-3642Recalls & reported problems
Stryker GmbH · Drill, AO · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04546540576798), received between Aug 3, 2020 and Dec 10, 2025 — classified as 4 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
- Fracture2
- Failure to Align1
Patient problems
- Foreign Body In Patient2
- Device Embedded In Tissue or Plaque1
- Insufficient Information1
- 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.
MalfunctionDec 10, 2025Failure to Align; Failure to Align
IT WAS REPORTED THAT "INCORRECT DRILLING OCCURRED DURING DISTAL LOCKING OF A GAMMA NAIL (LENGTH 200 MM)." PRE-OPERATING TESTING AND FINAL IMAGING WERE CONDUCTED. THE SURGERY WAS COMPLETED USING THE FREE-HAND TECHNIQUE. THE ACTIVITY LEVEL OF THE PATIENT WAS NORMAL AND THE PATIENT WAS COMPLIANT TO MOBILIZATION INSTRUCTIONS FROM THE SURGEON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23773180 ↗MalfunctionMar 27, 2023Break; Fracture; Break; Fracture
IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE TARGETER DEVICE AS WELL AS A BROKEN DRILL BIT. UPDATE ON 03.16.2023 : "THE DISTAL TARGETER MISSED THE NAIL HOLE ON A SHORT NAIL".
Patient problems: Insufficient Information
MAUDE report 16619044 ↗MalfunctionMay 14, 2021Break; Break
IT WAS REPORTED THAT THE DRILL BIT BROKE DURING SURGERY. ATTEMPTS MADE TO RETRIEVE THE BROKEN PART FROM THE PATIENT WERE UNSUCCESSFUL; THE BROKEN PART WAS LEFT IN THE PATIENT. NO ADVERSE CONSEQUENCE TO THE PATIENT HAS BEEN REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 11827187 ↗MalfunctionAug 3, 2020Fracture; Fracture
AS REPORTED: "BROKEN DRILL BIT DURING GAMMA NAIL DISTAL LOCKING DRILLING, RETAINED WITHIN NAIL.
Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient
MAUDE report 10358291 ↗
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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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