Peri-Loc 71173377Recalls & reported problems

Summary

The FDA's MAUDE database contains 401 adverse event reports that list this exact device (DI 03596010519535), received between Feb 6, 2019 and Oct 30, 2025 — classified as 31 injuries, 370 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (228 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 401 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 30, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN ORIF DISTAL HUMERUS SURGERY, IT WAS NOTICED THAT THE POINT TIP OF SIX (6) RDCE FRCPS W/ PTS BRD BROKE OR GOT BENT WHILE BEING APPLIED TO THE BONE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23431047 ↗
• MalfunctionJul 19, 2025Positioning Failure; Material Deformation; Positioning Failure; Material Deformation

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, TEN (10) RDCE FRCPS W/ PTS BRD WERE DULL AND NO LONGER CLAMPING ONTO BONE. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, WITH A SYNTHES COMPETITOR DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22551565 ↗
• MalfunctionMay 9, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING INTERNAL FIXATION FOR A FRACTURED ANKLE, THE SHARP ENDS ONE (1) RDCE FRCPS W/ PTS BRD SNAPPED OFF. ALL THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT WITH TWEEZERS. 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 21993463 ↗
• MalfunctionFeb 5, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE TIP OF THE RDCE FRCPS W/ PTS BRD FRACTURED WHILE DR. TRIED TO COMPRESS FRACTURE BY GRABBING PLATE AND SCREW. TIP OF THE FORCEPS BROKE OFF; PIECE DID NOT FALL INSIDE THE WOUND. BROKEN PIECE LANDED OUTSIDE THE PATIENT ON THE FLOOR. 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 21318194 ↗
• MalfunctionFeb 4, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION, THE TIP OF THE RDCE FRCPS W/ PTS BRD BROKE OFF. THE SURGERY WAS COMPLETED, WITHOUT ANY DELAY, WITH A S+N BACK-UP DEVICE. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21301489 ↗
• MalfunctionJan 16, 2025Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT DURING THE OSTEOSYNTHESIS PROCEDURE, THE RDCE FRCPS W/ PTS BRD JAW BROKE. THE ONLY FRAGMENT WAS EXTRACTED FROM THE PATIENT WITH FORCEPS. NO DAMAGE CAUSED. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. PATIENT'S HEALTH CONDITION IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21167475 ↗
• MalfunctionOct 29, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING SURGERY, THE POINTED TIP OF ONE (1) RDCE FRCPS W/ PTS {} BRD SNAPPED OFF WHEN THEY WERE USING IT TO REDUCE A FRACTURE. ALL THE PIECES WERE SUCCESSFULLY LOCATED. 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 20557975 ↗
• MalfunctionOct 4, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, THE END OF POINT OF A RDCE FRCPS W/ PTS BRD BROKE OFF. NOTHING WAS LEFT INSIDE OF THE PATIENT, THE PIECES WERE EXTRACTED WITH TWEEZERS. THERE WAS NO DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20369621 ↗
• MalfunctionSep 4, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION PROCEDURE, A RDCE FRCPS W/ PTS {} BRD BROKE WHEN REDUCING A FRACTURE. ALL PIECES WERE RETRIEVED WITH TWEEZERS. 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 20136327 ↗
• MalfunctionAug 22, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION PROCEDURE, THE RDCE FRCPS W/ PTS {} BRD WAS USED TO TRY AND REDUCE A SHORTENED TIBIA TO LENGTH. IT WAS NOTICED THAT THE TIP OF THE DEVICE HAD BROKEN OFF AND AN X-RAY CONFIRMED THAT THE PIECE IS STUCK IN THE BONE. ATTEMPTS TO REMOVE IT WERE UNSUCCESSFUL. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 20031252 ↗
• MalfunctionAug 15, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGERY THE SURGEON CLAMPED AROUND BONE AND METAL POINT OF ONE (1) RDCE FRCPS W/ PTS {} BRD SNAPPED. ALL METAL PIECES WERE EXTRACTED FROM STERILE FIELD. 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 19991567 ↗
• MalfunctionAug 5, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION PROCEDURE, A RDCE FRCPS W/ PTS {} BRD BROKE WHEN REDUCING FRACTURE. ALL PIECES WERE RETRIEVED WITH TWEEZERS. 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 19906820 ↗
• MalfunctionNov 20, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING TRAUMA SURGERY, THE TIPS OF THE RDCE FRCPS W/ PTS {} BRD BROKE OFF OF CLAMP. THE PROCEDURE WAS COMPLETED WITHOUT 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 18172697 ↗
• MalfunctionNov 18, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN ORIF CLAVICLE, WHILE USING ONE (1) RDCE FRCPS W/ PTS {} BRD, THE END POINT BROKE OFF WHEN TAKING THE CLAMP OFF THE PATIENT. NO PIECES FELL INSIDE 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 18166927 ↗
• MalfunctionNov 10, 2023Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, TWO (2) RDCE FRCPS W/ PTS BRD BROKE. IT IS UNKNOWN HOW PROCEDURE WAS COMPLETED OR IF A DELAY OCCURRED DUE TO THIS EVENT. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18116060 ↗
• MalfunctionNov 10, 2023Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, TWO (2) RDCE FRCPS W/ PTS {} BRD BROKE. IT IS UNKNOWN HOW PROCEDURE WAS COMPLETED OR IF A DELAY OCCURRED DUE TO THIS EVENT. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18115985 ↗
• MalfunctionOct 24, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION, THE TIP OF ONE END OF THE RDCE FRCPS W/ PTS BRD DEVICE BROKE OFF. THE CLAMP WAS REMOVED AND THE BROKEN TIP WAS LOCATED AND REMOVED FROM THE WOUND. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18000057 ↗
• MalfunctionSep 18, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN ORIF, THE TIP OF A RDCE FRCPS W/ PTS {} BRD BROKE. FURTHERMORE, THE BROKEN PIECE WAS LOST BUT IT WAS CONFIRMED THROUGH X-RAY THAT IT WAS NOT INSIDE THE PATIENT. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17766397 ↗
• MalfunctionMay 31, 2023Break; Break

  IT WAS REPORTED THAT, DURING ANKLE ORIF SURGERY, IT WAS NOTICED THAT, BOTH TIPS OF ONE (1) RDCE FRCPS W/ PTS {} BRD WERE BENT AND BROKE. SCRUB TECH TOSSED THEM INTO A SHARPS CONTAINER AND NOT RETRIEVABLE. 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 17035438 ↗
• MalfunctionMar 15, 2023Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, THE TIP OF AN RDCE FRCPS W/ PTS {} BRD BROKE OFF. IT IS UNKNOWN HOW THE SURGERY WAS COMPLETED OR IF THIS CAUSED A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16547225 ↗
• InjuryMar 3, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING USE, THE TIP OF AN RDCE FRCPS W/ PTS {} BRD BROKE OFF. ADDITIONALLY, SOME PIECES FELL INTO THE PATIENT BUT THEY WERE ACCOUNTED AND REMOVED WITH SUCTION. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16479831 ↗
• MalfunctionNov 29, 2022Fracture; Fracture

  IT WAS REPORTED THAT, A RDCE FRCPS W/ PTS BRD BROKE DURING A CASE. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15882804 ↗
• InjuryNov 7, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ORIF PILON, THE TIP OF AN RDCE FRCPS W/ PTS {} BRD BROKE OFF. THE PIECES THAT FELL INSIDE THE PATIENT WERE REMOVED WITH FORCEPS. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN S+N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15748941 ↗
• MalfunctionNov 1, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING ORIF SURGERY, THE TIP OF ONE (1) RDCE FRCPS W/ PTS {} BRD BROKE. 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 15711633 ↗
• MalfunctionOct 24, 2022Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING USE, A RDCE FRCPS W/ PTS {} BRD BROKE. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15664169 ↗

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