Peri-Loc 71173536Recalls & reported problems
Smith & Nephew, Inc. · 3.5MM CANNULATED HEXDRIVER SHAFT · Class 1
All models of Peri-Loc (102)
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 03596010519634), received between Dec 1, 2020 and Feb 5, 2023 — 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.
Most reported problems
Device problems
- Fracture2
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryFeb 5, 2023Fracture; Fracture
IT WAS REPORTED THAT DURING SURGERY A 3.5MM CANNULATED HEXDRIVER TIP SNAPPED OFF, AND THE PART WAS RETRIEVED. A 3.5MM CANNULATED HEXDRIVER BACKUP DEVICE WAS USED AND GOT STUCK INSIDE OF TEAR DROP SCREWDRIVER HANDLE WHILE USING IT. THE PROCEDURE WAS COMPLETED, WITHOUT ANY DELAY, USING A COMPETITOR DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16302082 ↗MalfunctionJun 22, 2022Fracture; Fracture
IT WAS REPORTED THAT DURING THR, THE TIP OF THE 3.5MM CANNULATED HEXDRIVER BROKE OFF. ALL PIECES WERE RECOVERED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY USING A SMITH+NEPHEW BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14777159 ↗InjuryDec 1, 2020Break; Break
IT WAS REPORTED THAT DURING SURGERY TWO HANDLES (TEAR DROP SCREWDRIVER HANDLE AND LARGE SCREWDRIVER HANDLE) AND TWO HEXDRIVERS (3.5MM S/R HEXDRIVER SH 178MM AND 3.5MM CANNULATED HEXDRIVER) BROKE AS A RESULT OF TRYING TO REMOVE SCREWS (INSIDE THE PATIENT). THE HANDLE GOT STUCK AND DRIVER COULD NOT BE REMOVED. IT IS UNKNOWN IF THERE WAS A DELAY OR A BACK UP AVAILABLE TO COMPLETE THE PROCEDURE. NO OTHER COMPLICATIONS WERE REPORTED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10928904 ↗
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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