NA 311.004Recalls & reported problems
Synthes GmbH · FIXED-SWIVEL SCREWDRIVER HANDLE · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10887587035567), received between Nov 8, 2018 and Apr 2, 2024 — classified as 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
- Device-Device Incompatibility1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- No Patient Involvement1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 2, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE SCREW DRIVER HANDLE IS NOT RATCHETING WHEN A SCREW DRIVER SHAFT IS PLACED IN IT DURING A SURGERY. IT IS UNKNOWN WHEN THE ISSUE WAS OBSERVED. IT IS UNKNOWN IF THERE IS PATIENT INVOLVEMENT. IT IS UNKNOWN IF REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION OCCURRED. THIS REPORT IS FOR ONE (1) SCREWDRIVER HANDLE LOCKABLE W/HEX-COUPL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: Insufficient Information
MAUDE report 19019804 ↗MalfunctionMar 25, 2021Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DRIVER HANDLE RATCHETING BUTTON WAS BROKEN OFF AND IT'S NOT ALLOWING TO FUNCTION PROPERLY. NO PATIENT INVOLVED IT WAS FOUND THIS WAY AFTER STERILIZING IN AUTOCLAVE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) FIXED-SWIVEL SCREWDRIVER HANDLE. THIS REPORT IS 1 OF 1 (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11571844 ↗MalfunctionNov 8, 2018Break; Break
IT WAS REPORTED THAT ON (B)(6) 2018 AT LOANERS DEPARTMENT, IT WAS NOTED THAT THE FIXED-SWIVEL SCREWDRIVER HANDLE WAS BROKEN WHEN SET WAS RECEIVED FROM FACILITY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) FIXED-SWIVEL SCREWDRIVER HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 8053566 ↗
Other SCREWDRIVER devices
- DELTA XTEND 2307-92-003Depuy (Ireland) · SCREWDRIVER751 reports
- EXPEDIUM 279712400Medos International Sàrl · SCREWDRIVER551 reports
- NA 314.467Synthes GmbH · SCREWDRIVER498 reports
- N/A 5584111Medtronic Sofamor Danek, Inc. · SCREWDRIVER492 reports
- QUICKSET 2274-47-000Depuy (Ireland) · SCREWDRIVER487 reports
- NA 03.130.010Synthes GmbH · SCREWDRIVER1 recall422 reports
- QUICKSET 2274-63-000Depuy (Ireland) · SCREWDRIVER404 reports
- EVOS 71175072Smith & Nephew, Inc. · SCREWDRIVER336 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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