NA 03.010.121Recalls & reported problems
Synthes GmbH · LARGE HEXAGONAL SCREWDRIVER 3.5MM WIDTH ACROSS FLATS · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982067890), received between Jun 29, 2018 and Jun 29, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
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
- Break1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 29, 2018Break; Break
IT WAS REPORTED THAT DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE HIP TO IMPLANT THE TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) SYSTEM, THE SURGEON EXPERIENCED AN ISSUE DURING THE PROCEDURE WITH THE HEXAGONAL SCREWDRIVER. THE WOODEN HANDLE WAS SPINNING AROUND THE SHAFT OF THE SCREWDRIVER AND THE SURGEON WAS UNABLE TO INSERT THE 5.0MM DISTAL LOCKING SCREW. ANOTHER SCREWDRIVER WAS USED AND THE SURGEON WAS ABLE TO PLACE THE LOCKING SCREW. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS REPORTED TO BE STABLE. CONCOMITANT DEVICES REPORTED: 130 DEGREE AIMING ARM SCREW ONLY (PART 03.037.115, LOT UNKNOWN, QUANTITY 1); 5.0MM TI LOCKING SCREW 34MM - FOR IM NAILS - STERILE (PART 458.934S, LOT UNKNOWN, QUANTITY 1). THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7652359 ↗
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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