NA B92Recalls & reported problems
Synthes GmbH · THUMB SCREW SUB-ASSEMBLY · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034801049), received between Feb 7, 2018 and Feb 7, 2018 — classified as 2 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.
Most reported problems
Device problems
- Break2
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 7, 2018Break; Break
IT WAS REPORTED THAT DURING A INTERNAL INSPECTION ACTIVITY BY THE DEPUY SYNTHES SERVICE AND REPAIR DEPARTMENT, TWO (2) DRIVE SHAFTS FOR USE THE (RIA) REAMER IRRIGATOR ASPIRATOR INSTRUMENT WERE FOUND WITH TIPS BROKEN ON EACH INSTRUMENT. NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES TWO (2) DEVICE. THIS REPORT IS FOR ONE (1) DRIVE SHAFT. THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7249308 ↗MalfunctionFeb 7, 2018Break; Break
IT WAS REPORTED THAT DURING A INTERNAL INSPECTION ACTIVITY BY THE DEPUY SYNTHES SERVICE AND REPAIR DEPARTMENT, TWO (2) DRIVE SHAFTS FOR USE THE (RIA) REAMER IRRIGATOR ASPIRATOR INSTRUMENT WERE FOUND WITH TIPS BROKEN ON EACH INSTRUMENT. NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES TWO (2) DEVICE. THIS REPORT IS FOR ONE (1) DRIVE SHAFT. THIS IS REPORT 2 OF 2 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7249306 ↗
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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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