Peri-Loc 71173547Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 03596010519580), received between Nov 16, 2018 and Jun 30, 2026 — classified as 5 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2026Fracture

  IT WAS REPORTED THAT, DURING A IMN FEMUR SURGERY, ONE (1) LARGE SCREWDRIVER HANDLE SNAPPED OFF. NO PIECES FELL INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25662663 ↗
• MalfunctionMay 15, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, ONE (1) LARGE SCREWDRIVER HANDLE BROKE AND WOULD NOT CAPTURE THE SCREWDRIVER. ALL THE PIECES WERE ACCOUNTED FOR. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22023797 ↗
• MalfunctionFeb 14, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION PROCEDURE, THE HANDLE PART OF ONE (1) LARGE SCREWDRIVER HANDLE SNAPPED WHILST SCREWING IN THE LARGE FRAG SCREW DURING PLATING. IT SNAPPED BETWEEN THE METAL AND WOODEN PART. AS IT ONLY BROKE INTO TWO, THE PIECES WERE RETRIEVED BY HAND. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18705883 ↗
• MalfunctionJun 5, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TRAUMA SURGERY (TIBIAL FRACTURE CASE), THE SCREWDRIVER COUPLER CAME UNSECURED FROM THE LARGE SCREWDRIVER HANDLE WHILE REMOVING SCREW. ALL PIECES WERE RECOVERED FROM THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17066511 ↗
• InjuryDec 13, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, WHILE REMOVING A SCREW FROM DISTAL FEMUR PLATE, A PERI-LOC LARGE SCREWDRIVER HANDLE BROKE WHILE INSIDE THE PATIENT. IT IS UNKNOWN IF ANY PIECES FELL INSIDE THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12988982 ↗
• MalfunctionAug 25, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, A LARGE SCREWDRIVER HANDLE BROKE DURING USE. INSTRUMENTS WERE OUTSIDE THE PATIENT. SURGERY WAS COMPLETED WITH A BACKUP DEVICE INSTEAD, WITHOUT ANY DELAY. NO HARM TO THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12367465 ↗
• InjuryJul 7, 2021Break; Break

  IT WAS REPORTED THAT, DURING TRAUMA SURGERY, A PERI-LOC LARGE SCREWDRIVER HANDLE BROKE INSIDE THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH & NEPHEW BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12130010 ↗
• MalfunctionJun 18, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, A PERILOC LRG SCREWDRIVER HANDLE WAS BROKEN BUT THE SHAFT OF THE DRIVER WAS STILL INTACT. THE PROCEDURE WAS COMPLETED WITH A LESS THAN 30 MINUTE SURGICAL DELAY. IT IS UNKNOWN HOW THE SURGERY WAS COMPLETED. PATIENT WAS NOT INJURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12022897 ↗
• MalfunctionMay 5, 2021Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE LARGE SCREWDRIVER HANDLE BROKE DURING USE OUTSIDE THE PATIENT. NO DELAYS WERE REPORTED AND THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11780716 ↗
• InjuryApr 23, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN UNKNOWN SURGERY, THE LARGE SCREWDRIVER HANDLE AO MECHANISM WAS BROKEN OUTSIDE OF THE PATIENT AND THAT THE SHAFT COULD NOT GET OUT. NO SIGNIFICANT SURGICAL DELAY IS REPORTED. SURGERY WAS COMPLETED USING A COMPETITORS DEVICE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11720743 ↗
• MalfunctionApr 20, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT, THE 2.5MM CANN HEXDRIVER SHAFT - 120MM LARGE SCREWDRIVER HANDLE ARE STUCK TOGETHER. INCIDENT OCCURRED AFTER THE PROCEDURE; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11693207 ↗
• MalfunctionMar 30, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT DURING A PERILOC L-P TIBIA PLATE REMOVAL, THE DR REMOVED PLATE AND SCREWS FOR A PATIENT THAT HEALED. ORIGINAL SURGERY WAS IN 2015 AT ST JOSEPH REGIONAL MEDICAL CENTER. DURING THE CASE THE SCREWDRIVER BECAME STUCK IN THE SCREWDRIVER HANDLE. THE CASE WAS COMPLETED AS EXPECTED AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11593485 ↗
• MalfunctionMar 11, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT A LARGE SCREWDRIVER HANDLE AND THE DRIVER DID NOT COME APART. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11458339 ↗
• MalfunctionFeb 21, 2021Connection Problem; Connection Problem

  (CASE: (B)(4) AND CASE: (B)(4)) IT WAS REPORTED THAT AFTER STERILIZATION, THE TEAR DROP SCREWDRIVER HANDLE AND THE 3.5MM CANNULATED HEXDRIVER ARE STUCK. NO CASE INVOLVED. (CASE: (B)(4) AND CASE: (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 11356774 ↗
• InjuryFeb 21, 2021Break; Break

  IT WAS REPORTED DURING A PRIMARY PROCEDURE THAT THE SHAFT OF A LARGE SCREWDRIVER HANDLE BROKE OFF INSIDE THE PATIENT AND THE SURGEON REMOVED THE BROKEN PIECES FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY, USING A BACKUP FROM SMITH & NEPHEW. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11356669 ↗
• MalfunctionJan 28, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT, LARGE SCREWDRIVER HANDLE DEVICE IS LOCKED UP. NO CASE INVOLVED; THEREFORE, NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11242895 ↗
• MalfunctionJan 26, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT AFTER A PROCEDURE, THE DEVICE HAD BECOME WEDGED IN DRIVER HANDLE AND WAS UNABLE TO BE REMOVED. THE PROCEDURE FINISHED WITH THE SAME DEVICE. NO SURGICAL DELAY. PATIENT INJURIES WERE NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11232566 ↗
• InjuryDec 1, 2020Connection Problem; Connection Problem

  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 10928957 ↗
• MalfunctionSep 28, 2020Defective Device; Defective Device

  IT WAS REPORTED AFTER THE PROCEDURE, THE DRIVER SHAFT SEIZED INTO A LARGE FRAG HANDLE. THE PROCEDURE THAT WAS PERFORMED BEFORE WAS COMPLETED USING THE SAME DEVICE AND WITHOUT DELAY. NO PATIENT INJURY OR OTHER COMPLICATION 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 10597595 ↗
• MalfunctionSep 15, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE T25 SELF-RET SCREWDRIVER W/QC 203MM AND LARGE SCREWDRIVER HANDLE INSTRUMENTS ARE STUCK TOGETHER. UNKNOWN IF PATIENT INVOLVED OR PROCEDURE BEING PERFORMED.

  Patient problems: No Information

  MAUDE report 10537752 ↗
• MalfunctionAug 28, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT THE 2.5MM CANNULATED SCREW DRIVER SHAFT BECAME STUCK INSIDE OF THE LARGE SCREWDRIVER HANDLE. NO CASE, THEREFORE, NO PATIENT WAS INVOLVED. BACKUP DEVICE WAS AVAILABLE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10468527 ↗
• MalfunctionAug 24, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT AFTER THE PROCEDURE, THE DRIVER HANDLE WAS ATTACHED TO THE DRIVER SHAFT. THE PROCEDURE WAS COMPLETE WITHOUT DELAY AND WITH THE SAME DEVICE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10446366 ↗
• MalfunctionAug 20, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING SURGERY, WHEN THE SURGEON WAS TIGHTENING THE SCREW, THE LARGE SCREWDRIVER HANDLE STRIPPED. THE PROCEDURE WAS FINISHED USING A SMITH AND NEPHEW BACK UP DEVICE, WITH NO SURGICAL DELAY AND NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10429312 ↗
• MalfunctionAug 16, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING SURGERY OUTSIDE OF THE PATIENT THESE TWO ITEMS GOT STUCK TOGETHER/WILL NOT SEPARATE. THERE WAS NO INJURY REPORTED. IT IS UNKNOWN IF THERE WAS ANY DELAY OR HOW WAS THE PROCEDURE FINISHED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10411834 ↗
• MalfunctionJul 21, 2020Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT DURING INSPECTION WAS FOUND THAT THE LARGE SCREWDRIVER HANDLE HAS A HEX DRIVER STUCK IN IT. THERE WAS NO CASE INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10302036 ↗

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