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
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
- NA 03.607.513Synthes GmbH · CUTTER, WIRE35 reports
- NA 03.221.006Synthes GmbH · CUTTER, WIRE34 reports
- NA 388.72Synthes GmbH · CUTTER, WIRE29 reports
- NA 03.221.008Synthes GmbH · CUTTER, WIRE11 reports
- NA 391.771Synthes GmbH · CUTTER, WIRE8 reports
- NA 391.906Synthes GmbH · CUTTER, WIRE8 reports
- NA 391.905Synthes GmbH · CUTTER, WIRE7 reports
- Tecomet AR-9938-11Tecomet Inc. · Cutter, Wire6 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.