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Peri-Loc 71173540Recalls & reported problems

Smith & Nephew, Inc. · 4.7MM HEXDRIVER · Class 1

All models of Peri-Loc (102)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
4
Deaths reported
0
Injuries reported
4
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010519672), received between May 25, 2021 and Apr 4, 2022 — classified as 4 injuries.

The most frequently reported specific device problem is “Break” (4 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

  • Break4

Patient problems

  • No Clinical Signs, Symptoms or Conditions4

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • InjuryApr 4, 2022Break; Break

    IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, WHILE TIGHTENING A SCREW, THE TIP OF A 4.7MM HEXDRIVER BROKE OFF. SURGERY WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED BEYOND THE ISSUE REPORTED. NO FURTHER COMPLICATIONS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13996219 ↗
  • InjuryJan 27, 2022Break; Break

    IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, FOR REMOVAL OF PERILOC LARGE FRAG PROXIMAL FEMUR PLATE, THE 4.7MM HEXDRIVER BEING USED TO REMOVE LARGE SCREW HEADS HAD BROKEN DISTALLY. AS THE SCREWDRIVER WAS BEING USED IN A REMOVAL, AN AUDIBLE SHEERING SOUND WAS MADE AND SMALL PIECE OF METAL WAS REMOVED FROM THE 4.7MM HEXDRIVER. ALSO, A CLOSER INSPECTION OF WHERE THE INSTRUMENT FAILED WAS NOT ABLE TO OCCUR FOR SPECIAL PRECAUTIONS FOR PATIENT WITH HIV. NEVERTHELESS, ALL THE BROKEN PIECES WERE RETRIEVED, ACCOUNTED AND REMOVED WITH PICKUPS. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A COMPETITOR DEVICE. PATIENT WAS NOT HARMED, OR FURTHER COMPLICATIONS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13365229 ↗
  • InjuryOct 20, 2021Break; Break

    IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE TIP OF A 4.7MM HEXDRIVER BROKE OFF IN SCREW HEAD WHILE REMOVING FROM 4.5 FEMUR PLATE. TIP WAS RETRIEVED AND THE WOUND WAS IRRIGATED. SURGERY WAS FINISHED WITH A S&N BACKUP DEVICE, WITHOUT ANY SURGICAL DELAY. NO HARM TO PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12666163 ↗
  • InjuryMay 25, 2021Break; Break

    IT WAS REPORTED THAT, DURING TRAUMA PROCEDURE, THE 4.7MM HEXDRIVER BROKE WHILE IN USE INSIDE THE PATIENT. IF IS UNKNOWN HOW THE PIECES WERE RETRIEVED AND IF THERE WAS ANY SURGICAL DELAY. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11881838 ↗

Other SCREWDRIVER devices

All SCREWDRIVER devices →

Sources and updates

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