Peri-Loc 71173543Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010519610), received between Nov 10, 2020 and Mar 1, 2021 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K122170); they may or may not involve this specific model.

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

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 1, 2021Separation Problem; Separation Problem

  IT WAS REPORTED THAT, DURING INSPECTION THE TEAR DROP SCREWDRIVER HANDLE WAS HOLDING THE DRIVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11396761 ↗
• MalfunctionFeb 21, 2021Connection Problem; Connection Problem

  ((B)(4)) IT WAS REPORTED THAT AFTER STERILIZATION, THE TEAR DROP SCREWDRIVER HANDLE AND THE 3.5MM CANNULATED HEXDRIVER ARE STUCK. NO CASE INVOLVED. ((B)(4)) IT WAS REPORTED THAT AFTER STERILIZATION, THE LARGE SCREWDRIVER HANDLE AND THE T25 SELF-RET SCREWDRIVER W/QC 178MM ARE STUCK. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11356771 ↗
• MalfunctionFeb 14, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT, THE DRIVER OF A TEAR DROP SCREWDRIVER HANDLE GOT STUCK IN THE HANDLE AND WILL NOT DISENGAGE. IT IS UNKNOWN WHETHER THE EVENT HAPPENED AND IF THERE WAS A PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11326214 ↗
• InjuryDec 4, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING SURGERY, THE TEAR DROP SCREWDRIVER HANDLE GOT STUCK. 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 10945001 ↗
• MalfunctionNov 10, 2020Defective Device; Connection Problem; Defective Device; Connection Problem

  IT WAS REPORTED THAT A 2.5MM HEX DRIVER LONG GOT STUCK IN HANDLE AND WOULD NOT RELEASE. FAULT IN DEVICE WAS NOTICED AFTER PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE, THEREFORE, NO BACKUP WAS NEEDED. NO SURGICAL DELAY OR INJURY TO THE PATIENT WAS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10818505 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K122170. One submission often covers many models, so check the product and lot details in each record.

• Z-0351-2020 · Oct 7, 2019 · Terminated
  LAG SCREW 3.2MM GUIDE PIN SLEEVE, REF 71674032 - Product Usage: The TRIGEN InterTAN nails are indicated for fractures of the femur including: simple shaft fractures, comminuted sha