Peri-Loc 71173378Recalls & reported problems

Summary

The FDA's MAUDE database contains 68 adverse event reports that list this exact device (DI 03596010519542), received between Mar 20, 2018 and Apr 14, 2026 — classified as 5 injuries, 63 malfunctions.

The most frequently reported specific device problem is “Break” (37 reports).

2 other recalls cover devices cleared under the same FDA submission (K123598); 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 68 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 14, 2026Break

  IT WAS REPORTED THAT, DURING A OSTEOSYNTHESIS SURGERY, WHEN HANDLING ONE (1) RDCE FRCPS W/ SRRTD JW AND CLOSING IT, IT BROKE. 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 24872938 ↗
• MalfunctionJan 16, 2026Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, A CLAMP OF ONE (1) RDCE FRCPS W/ SRRTD JW BROKE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED OR IF THIS CAUSED ANY DELAY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24102779 ↗
• MalfunctionAug 10, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, THE JAW OF ONE RDCE FRCPS W/ SRRTD JW SNAPPED WHEN BEING TIGHTENED. THE PROCEDURE WAS RESUMED WITHOUT ANY SURGICAL 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 22767950 ↗
• MalfunctionAug 6, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, ONE (1) RDCE FRCPS W/ SRRTD JW SNAPPED ON THE SERRATED PART, RESULTING IN A CLEAN BREAK INTO TWO SEPARATE PIECES. ALL FRAGMENTS WERE SUCCESSFULLY RETRIEVED. 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 22723994 ↗
• MalfunctionMay 15, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, WHEN REDUCING THE FRACTURE WITH ONE (1) RDCE FRCPS W/ SRRTD JW IT DID NOT GRASP THE FRAGMENT, BUT THE CLAMP BROKE. 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 22024908 ↗
• MalfunctionOct 12, 2024Fracture; Fracture

  IT WAS REPORTED THAT, WHILE CLAMPING THE FIBULA, DURING AN ORIF SURGERY, ONE (1) RDCE FRCPS W/ SRRTD JW BROKE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED, AND IF THERE WAS SURGICAL DELAY. NO INJURY WAS REPORTED AS A RESULT OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20435490 ↗
• MalfunctionApr 11, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A PLATE SURGERY, ONE (1) RDCE FRCPS W/ SRRTD JW FRACTURED WHEN PRESSURE WAS APPLIED WHILE USING THEM TO REDUCE A BONE FRAGMENT. NO PIECES FELL INTO PATIENT AND ALL PIECES WERE ACCOUNTED. 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 19094026 ↗
• MalfunctionMar 25, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION PROCEDURE, THE SERRATED TEETH OF ONE PART OF A RDCE FRCPS W/ SRRTD JW SNAPPED OFF. 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 18969427 ↗
• MalfunctionDec 1, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A EVOS PROCEDURE, WHEN USING CLAMP TO CLAMP A PLATE TO THE BONE, (1) ONE PRONG OF A RDCE FRCPS W/ SRRTD JW SNAPPED OFF. ALL PIECES WERE RECOVERED WITH TWEEZERS. PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18251232 ↗
• MalfunctionAug 30, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A PROCEDURE, WHILE TRYING TO SQUEEZE A FRACTURE, A RDCE FRCPS W/ SRRTD JW SNAPPED. HOWEVER, THE BROKEN PIECE WAS VERY EASY TO REMOVE, THEREFORE, NOTHING WAS LEFT IN THE PATIENT, THE SURGEON USED HIS FINGERS TO GRAB THE SINGULAR PIECE THAT BROKE OFF, IT TOOK MAYBE 3 SECONDS. PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17657895 ↗
• MalfunctionAug 9, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, ONE OF THE JAWS OF A RDCE FRCPS W/ SRRTD JW HAD BROKEN OFF. 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 17487158 ↗
• InjuryMar 13, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A POLYTRAUMA CASE, ONE OF THE POINTS OF A RDCE FRCPS W/ SRRTD JW BROKE OFF. EVEN THOUGH PIECES FELL INTO THE PATIENT THEY WERE ACCOUNTED AND REMOVED WITH SUCTION. HOWEVER, IT REMAINS UNCLEAR HOW THE PROCEDURE WAS FINISHED AND IF THERE WAS A DELAY. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16527335 ↗
• MalfunctionMar 6, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TRAUMA SURGERY, THE SERRATED JAW OF ONE (1) RDCE FRCPS W/ SRRTD JW BROKE OFF WHEN THE SURGEON CLAMPED A PLATE ONTO AN ULNA BONE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A COMPETITOR DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16492971 ↗
• MalfunctionJan 4, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE CLAMP OF ONE (1) RDCE FRCPS W/ SRRTD JW BROKE WHEN USED. 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 16095936 ↗
• MalfunctionOct 26, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING PRODUCT DECONTAMINATION, A REDUCTION FORCEPS W/ SERRATED JAW WAS BROKEN, IT IS UNKNOWN HOW OCCURRED. AS THIS WAS NOTICED UPON CLEANING AND STERILIZATION ACTIVITIES, THERE WAS NOT PATIENT INVOLVEMENT. A VISUAL INSPECTION CONFIRMED THE TIP OF THE DEVICE IS FRACTURE, RENDERING IT INOPERATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15674099 ↗
• MalfunctionAug 17, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE TIPS OF TWO (2) REDUCTION FORCEPS W/ SERRATED JAW AND TWO (2) REDUCTION FORCEPS W/ POINTS BROAD ARE BROKEN, A 2.0/2.7MM DOUBLE-ENDED DRILL GUIDE HAS SOMETHING STUCK IN THE 2.0 SLEEVE, AND THE 1.5/2.0MM DOUBLE-ENDED DRILL GUIDE IS MISSING SLEEVES. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15242716 ↗
• MalfunctionMay 23, 2022Fracture; Fracture

  IT WAS REPORTED THAT, A RDCE FRCPS W/ SRRTD JW TIP WAS FRACTURE. IT IS UNKNOWN WHEN THE EVENT HAPPENED OR IF THERE WAS ANY DELAY NOR INJURY REPORTED. IT IS UNKNOWN IF THERE WAS A S&N BACKUP DEVICE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14470650 ↗
• MalfunctionMay 18, 2022Break; Break

  IT WAS REPORTED THAT THE RDCE FRCPS W/ SRRTD JW BROKE. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14432155 ↗
• MalfunctionFeb 2, 2022Break; Break

  IT WAS REPORTED THAT THE RDCE FRCPS W/ SRRTD JW WAS BROKEN NEAR THE TIP. SINCE THIS WAS NOTICED DURING A FIELD INSPECTION, NO CASE WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13430508 ↗
• MalfunctionJan 4, 2022Break; Break

  IT WAS REPORTED THAT, THE LOBSTER CLAW OF A RDCE FRCPS W/ SRRTD JW IS BROKEN. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13159321 ↗
• MalfunctionJan 4, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, A REDUCTION FORCEPS W/ SERRATED JAW BROKE DURING USE AND EXTERNAL TO THE PATIENT. IT IS UNKNOWN IF ANY PIECES FELL INSIDE THE PATIENT. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT 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 13152643 ↗
• MalfunctionDec 15, 2021Break; Break

  IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION SURGERY, THE TIP OF RDCE FRCPS W/ SRRTD JW BROKE OFF. SURGERY HAD BEEN COMPLETED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. SINCE INCIDENT OCCURRED AFTER PROCEDURE, PATIENT WAS NOT LONGER INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13010643 ↗
• MalfunctionNov 25, 2021Break; Break

  IT WAS REPORTED THAT THE CLAWS OF A REDUCTION FORCEPS W/ SERRATED JAW ARE BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12876144 ↗
• MalfunctionNov 19, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN UNKNOWN SURGERY, A RDCE FRCPS W/ SRRTD JW BROKE AND A 2.0/2.7MM DOUBLE-ENDED DRILL GUIDE HAD A DRILL BIT STUCK IN IT. INCIDENTS OCCURRED OUTSIDE THE PATIENT. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED; HOWEVER, NO DELAY WAS REPORTED. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12844200 ↗
• MalfunctionNov 19, 2021Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, A DRILL GOT STUCK IN A 2.0/2.7MM DOUBLE-ENDED DRILL GUIDE AND A RDCE FRCPS W/ SRRTD JW BROKE. INCIDENTS OCCURRED OUTSIDE THE PATIENT. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED; HOWEVER, NO DELAY WAS REPORTED. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12843903 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123598. One submission often covers many models, so check the product and lot details in each record.

• Z-0730-2019 · Jan 7, 2019 · Terminated
  SL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM, S&N 75004613
• Z-1008-2017 · Nov 16, 2016 · Terminated
  REFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & Nephew, Inc,. Memphis, TN 38116