1.3 SQUARE SCREWDRIVER 2312-18-012 (REF 231218012)Recalls & reported problems
Biomet Orthopedics, LLC · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887868026324), received between Jul 22, 2020 and Jul 10, 2025 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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
- Fracture2
- Naturally Worn1
Patient problems
- Foreign Body In Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 10, 2025Naturally Worn; Naturally Worn
IT WAS REPORTED THAT DURING SURGERY THE SQUARE DRIVER COULD NOT BE USED DUE TO THE TIP BEING MISSHAPED. NO COMPLICATIONS, INJURIES, OR SURGICAL INTERVENTIONS WERE REQUIRED, AND NO FOREIGN BODIES WERE RETAINED DUE TO THIS MALFUNCTION. THE CASE WAS COMPLETED WITHOUT ANY ADVERSE OUTCOMES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED. DEVICE EVALUATION OF THE PRODUCT CONFIRMED THAT THE TIP WAS FRACTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22469541 ↗InjuryMar 31, 2021Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS EVENT.
Patient problems: Foreign Body In Patient
MAUDE report 11595624 ↗InjuryJul 22, 2020Fracture; Fracture
IT WAS REPORTED THAT THE SCREWDRIVER BROKE DURING THE SURGERY, WITH THE BROKEN PIECE NOT ABLE TO BE REMOVED FROM THE SCREW HEAD. THE BROKEN PIECE IS RETAINED IN THE PATIENT BODY. THERE WAS A SURGICAL DELAY OF 10 MINUTES. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 10307345 ↗
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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