Peri-Loc 71173370Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03596010519511), received between Oct 24, 2019 and May 18, 2022 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMay 18, 2022Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, THE REDUCE FRCP W/RCHT BOWED BROKE AT THE INTERFACE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED OR IF THERE WAS A DELAY DUE TO THIS EVENT. NO OTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14429901 ↗
• MalfunctionFeb 5, 2021Break; Break

  IT WAS REPORTED THAT DURING A TRAUMA CASE THE RDUCE FRCP W/RCHT BOWED 205MM BROKE. THIS HAPPENED OUTSIDE THE PATIENT. NO INJURY, NO DELAY. S+N BACKUPS TO ALL. 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 11283955 ↗
• MalfunctionNov 13, 2020Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE REDUCE FRCP W/RCHT BOWED 205MM BROKE. THIS HAPPENED DURING USE OUTSIDE THE PATIENT. THERE WAS NO DELAY. PROCEDURE CONCLUDED WITH A S&N BACK UP DEVICE. NO INJURIES REPORTED AT THIS TIME. 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 10838952 ↗
• MalfunctionNov 13, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A CLAM ON THE FORCEPS HAS WORN DOWN AND IS VERY LOOSE. NO CASE OR PATIENT INVOLVED. 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; No Patient Involvement

  MAUDE report 10838612 ↗
• MalfunctionAug 28, 2020Break; Break

  IT WAS REPORTED THAT THE SCREW HOLDING THE FORCEPS TOGETHER BROKE. THIS EVENT OCCURRED DURING SET UP OR INSPECTION (NO PATIENT INVOLVED). THE PROCEDURE WAS COMPLETED USING A SN BACKUP DEVICE. NO DELAY WAS REPORTED. 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 10468559 ↗
• MalfunctionOct 24, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT DURING INTRAMEDULLARY TIBIA NAILING PROCEDURE THE TIP OF THE FORCEPS WAS FOUND TO BE BENT OUT OF ALIGNMENT. A COMPETITOR BACKUP WAS USED TO COMPLETE THE PROCEDURE. DELAY REPORTED WAS LESS THAN 5 MINUTES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9234625 ↗

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