NA 03.501.042Recalls & reported problems
Synthes GmbH · 2.2MM DRILL BIT STRYKER J-LATCH/WITH 12MM STOP/135MM · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10887587010687), received between May 29, 2025 and Jul 31, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Material Integrity Problem” (3 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Material Integrity Problem3
- Failure to Cut2
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 31, 2025Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE SELF-FASTENING LONG SCREWDRIVER PART HAS THE TIP VERY WORN AND DOES NOT HAVE GOOD GRIP OF THE SCREWS. THERE WAS NO DISCOMFORT OF THE SPECIALIST, THE SURGERY ENDED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22676250 ↗MalfunctionJul 31, 2025Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE SELF-FASTENING LONG SCREWDRIVER PART HAS THE TIP VERY WORN AND DOES NOT HAVE GOOD GRIP OF THE SCREWS. THERE WAS NO DISCOMFORT OF THE SPECIALIST, THE SURGERY ENDED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22676221 ↗MalfunctionJul 31, 2025Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE SELF-FASTENING LONG SCREWDRIVER PART HAS THE TIP VERY WORN AND DOES NOT HAVE GOOD GRIP OF THE SCREWS. THERE WAS NO DISCOMFORT OF THE SPECIALIST, THE SURGERY ENDED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22676179 ↗MalfunctionJul 25, 2025Failure to Cut; Failure to Cut
IT WAS REPORTED THAT ONE OF THE MATRIXRIB 2.2 C/TOP L135/12 BITS IS UNEDGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22621156 ↗MalfunctionMay 29, 2025Failure to Cut; Failure to Cut
IT WAS REPORTED THAT DURING SURGERY, THE HANDLE WAS GETTING STUCK. TO ACTIVATE THE RACHE SYSTEM, SPECIALIST EXPRESSED DISAGREEMENT. DRILL BITS WERE WITHOUT EDGES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22106553 ↗
Other BIT, DRILL devices
- QUICKSET 2274-25-500Depuy Orthopaedics, Inc. · BIT, DRILL1,985 reports
- QUICKSET 2274-35-500Depuy Orthopaedics, Inc. · BIT, DRILL770 reports
- QUICKSET 2274-30-500Depuy Orthopaedics, Inc. · BIT, DRILL761 reports
- NA 03.037.022Synthes GmbH · BIT, DRILL339 reports
- NA 323.062Synthes GmbH · BIT, DRILL309 reports
- QUICKSET 2274-56-000Depuy (Ireland) · BIT, DRILL275 reports
- QUICKSET 2274-45-500Depuy Orthopaedics, Inc. · BIT, DRILL211 reports
- LCS 2366-83-000Depuy (Ireland) · BIT, DRILL207 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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