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NA 391.93Recalls & reported problems

Synthes GmbH · WIRE CUTTER 220MM · Class 1

Adverse event reports
9
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886982198440), received between May 24, 2017 and Jun 16, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (7 reports).

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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 1 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 1 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break7
  • Corroded1
  • Detachment of Device or Device Component1
  • Device Operates Differently Than Expected1
  • Dull, Blunt1
  • Material Integrity Problem1
  • Material Twisted/Bent1

Patient problems

  • No Clinical Signs, Symptoms or Conditions5
  • No Patient Involvement2
  • No Consequences Or Impact To Patient1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 16, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

    IT WAS REPORTED THE BLADE WAS WORN AND CHIPPING. ISSUE UNREPAIRABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22212962 ↗
  • MalfunctionJul 1, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

    IT WAS REPORTED THAT DURING SURGERY ON AN UNKNOWN DATE IN 2024, ONE OF THE SCREWS OF THE ITEM BROKE AND FELL OUT. THERE WAS NO PATIENT CONSEQUENCE. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT INVOLVES ONE WIRE CUTTER 220MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19645908 ↗
  • MalfunctionJan 11, 2023Break; Break

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE REPORTED PRODUCTS WERE BROKEN/DAMAGED. NO PATIENT CONSEQUENCE WAS REPORTED. THIS REPORT IS FOR ONE WIRE CUTTER 220MM THIS IS REPORT 1 OF 7 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16137090 ↗
  • MalfunctionDec 19, 2022Break; Break

    DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT UPON INSPECTION IN MDR, THE DEVICE HAS A DISTAL CONNECTOR MECHANISM THAT IS BROKEN. THE REPORTED ISSUE WAS IDENTIFIED DURING THE STERILIZATION AND INSPECTION PROCESS. THERE WERE NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE DEVICE. THIS REPORT IS FOR ONE WIRE CUTTER 220MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16003586 ↗
  • MalfunctionApr 29, 2022Corroded; Material Integrity Problem; Corroded; Material Integrity Problem

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING INSPECTION OF THE BACK UP DEVICES IT WAS DISCOVERED THAT THE GOLD PEG OF ONE (1) RECON LOCKING AIMING ARM FOR LFN NAILS-EX HAS SNAPPED OFF, THE THREADS OF ONE (1) EXTRACTION SCREW FOR TI FEMORAL & TIBIAL NAILS AND ONE (1) EXTRACTION SCREW/M8 FOR SUPRAPATELLAR ARE STRIPPED, AND ONE (1) DEPTH GAUGE FOR 2.0/2.4 AND 2.7 SCREWS WAS STUCK IN PLACE. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 5 OF 5 FOR COMPLAINT (B)(4). THIS COMPLAINT IS FOR A WIRE CUTTER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14251470 ↗
  • MalfunctionFeb 19, 2020Break; Break

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE WIRE CUTTER LEAF SPRING WAS BROKEN. NO PATIENT INVOLVEMENT WAS REPORTED. THIS REPORT IS FOR ONE (1) WIRE CUTTER 220MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9727284 ↗
  • MalfunctionJun 1, 2018Dull, Blunt; Device Operates Differently Than Expected; Dull, Blunt; Device Operates Differently Than Expected

    IT WAS REPORTED THAT DURING A PROCEDURE THAT WAS PERFORMED ON DOG, AS THE SURGEON WAS CUTTING A PIN IMPLANT, THE WIRE CUTTER INSTRUMENT WOULD NOT CLOSE. IT WAS NOTED THAT A NECESSARY COMPONENT PIECE ON THE INSTRUMENT WAS MISSING. NO ADDITIONAL TIME WAS ADDED DUE TO THIS EVENT. SURGERY WAS COMPLETED SUCCESSFULLY WITH ANOTHER LIKE INSTRUMENT. DURING MANUFACTURER¿S INVESTIGATION OF THE RETURNED DEVICE IT WAS IDENTIFIED THAT THE CUTTING EDGES OF THE DEVICE ARE WORN AND CHIPPED. THIS CONDITION WAS RE-EVALUATED AND DETERMINED TO BE REPORTABLE ON JUNE 1, 2018. CONCOMITANT DEVICE REPORTED: UNKNOWN PIN (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7562601 ↗
  • MalfunctionMay 4, 2018Break; Break

    IT WAS REPORTED THAT THE WIRE CUTTER 220MM IS PITTED. THIS ISSUE WAS DISCOVERED UPON ROUTING EXAMINATION. NO HOSPITAL OR PATIENT INVOLVEMENT. EVALUATION OF THE RETURNED DEVICE REVEALED THE CUTTING JAWS WERE CHIPPED IN THREE (3) PLACES AND A PIECE WAS BROKEN OFF. THIS REPORT IS FOR ONE (1) 220MM WIRE CUTTER THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Patient Involvement

    MAUDE report 7486551 ↗
  • MalfunctionMay 24, 2017Break; Break

    (B)(4) REPORTED THAT CUTTING TIP WAS FOUND BROKEN OFF. THERE WAS NO REPORTED PATIENT INVOLVEMENT. IT IS NOT KNOWN WHEN OR HOW THE TIP BROKE OFF. THERE IS ONE DEVICE ON THIS COMPLAINT. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Patient problems: No Patient Involvement

    MAUDE report 6587996 ↗

Other CUTTER, WIRE devices

All CUTTER, WIRE devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.