PlusDrive 313.252Recalls & reported problems
Synthes GmbH · 1.5MM/2.0MM SCRWDRVR BLD HXC SLF-RETAIN PLUSDRIVE(TM) 96MM · 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 10887587036700), received between Jan 7, 2019 and Feb 6, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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
- Device-Device Incompatibility2
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 6, 2023Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED ON (B)(6) 20233 THAT THE SCRUB NURSE WAS UNABLE TO LOAD THE SCREWDRIVER INTO THE HANDLE, THEY TRIED A DIFFERENT HANDLE BUT THE SCREWDRIVER WOULD NOT ENGAGE SO THEY TRIED THE ORIGINAL HANDLE WITH A NEW SCREWDRIVER AND THIS STILL WOULDN¿T ENGAGE. UPON TRYING A DIFFERENT SCREWDRIVER WITH A DIFFERENT HANDLE THESE ENGAGED AS THEY SHOULD. IT IS PRESUMED THE ORIGINAL HANDLE AND SCREWDRIVER SHAFT WERE BOTH FAULTY. THE SURGERY WAS COMPLETED IN A TIMELY MANNER AND THERE WERE NO OTHER COMPLICATIONS . THERE WAS NO PATIENT IMPACT AND THE PROCEDURE WAS NOT DUE TO THE FAILURE. THE PATIENT IS DOING WELL. THIS REPORT IS FOR ONE (1) SCRDRIVER SHAFT PLUSDRIVE 1.5/2 LONG SEL. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16306548 ↗MalfunctionJan 7, 2019Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT DURING A ROUTINE FIELD INSPECTION ON UNKNOWN DATE, ONE (1) SCREWDRIVER HANDLE WITH HEX COUPLING-LARGE AND ONE (1) SCREWDRIVER BLADE WOULD NOT COME APART FROM EACH OTHER. ONE (1) LOW PROFILE NEURO COMPACT MODULE WOULD NOT SHUT. THERE WAS NO PROCEDURE AND PATIENT INVOLVEMENT. THIS REPORT IS FOR A 1.5MM/2.0MM SCREWDRIVER BLADE. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 8222283 ↗
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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