NA 03.221.006Recalls & reported problems
Synthes GmbH · CABLE CUTTER W/TRIGGER HANDLE · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Synthes cable cutter with trigger handle is used to cut cables during surgery. Most reports describe the tool breaking, cracking or wearing down, sometimes coming apart into multiple pieces mid-procedure, and in one case the locking mechanism failed so the cutter could no longer be assembled. Some instruments showed corrosion and chipping, leading hospital reprocessing departments to refuse to clean them. There are 36 reports, with no deaths and no injuries.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 34
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10886982076694), received between Jul 18, 2017 and Jun 2, 2026 — classified as 34 malfunctions.
The most frequently reported specific device problem is “Break” (31 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break31
- Device Slipped3
- Corroded2
- Device-Device Incompatibility2
- Component Missing1
- Crack1
- Detachment of Device or Device Component1
- Failure to Cut1
Patient problems
- No Clinical Signs, Symptoms or Conditions26
- Insufficient Information5
- No Patient Involvement2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 2, 2026Break
IT WAS REPORTED ON (B)(6) 2026 THAT THE CABLE CUTTER FROM THE CABLE SET BROKE DURING THE CASE.
Patient problems: Insufficient Information
MAUDE report 25361102 ↗MalfunctionMar 30, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT THE CABLE CUTTER W/TRIGGER HANDLE CAME APART DURING A SURGICAL PROCEDURE. THE DEVICE BROKE INTO MULTIPLE PIECES INTRAOPERATIVELY WHILE BEING USED TO IMPLANT CABLES. THE BACKUP CABLE CUTTER WAS USED WITHOUT ISSUE, AND THE ORIGINAL DEVICE WAS RENDERED UNUSABLE AND REQUIRED REPLACEMENT. THERE WAS NO REPORTED CONSEQUENCE OR IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24727136 ↗MalfunctionJan 14, 2026Break; Corroded; Material Twisted/Bent
IT WAS REPORTED THAT GRAPHICS CASES AND INSTRUMENTS ARE CHIPPING AND SHOWING SIGNS OF CORROSION OR WEAR AND BREAKING DOWN SO THE CSPD DEPARTMENT REFUSES TO REPROCESS THEM. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24066498 ↗MalfunctionJan 13, 2026Break; Corroded; Material Discolored
IT WAS REPORTED THAT GRAPHICS CASES AND INSTRUMENTS ARE CHIPPING AND SHOWING SIGNS OF CORROSION OR WEAR AND BREAKING DOWN; THE CSPD DEPARTMENT REFUSES TO REPROCESS THEM. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24053646 ↗MalfunctionNov 3, 2025Break; Break
IT WAS REPORTED ON AN UNKNOWN DATE THAT TRIGGER HANDLE BROKE OFF. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23452315 ↗MalfunctionAug 15, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE LOCKING MECHANISM TO THE CABLE CUTTER WAS BROKEN INTRAOPERATIVELY. IT WILL NOT ALLOW THE CUTTER TO BE ASSEMBLED CORRECTLY, LOST FUNCTIONALITY. SURGICAL DELAY WAS UNKNOWN. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 22814529 ↗MalfunctionJul 8, 2025Break; Break
IT WAS REPORTED THAT THE HANDLE OF THE CABLE CUTTER WITH TRIGGER GRIP BROKE. THE ISSUE OCCURRED POT-OP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22437189 ↗MalfunctionJul 8, 2025Break; Break
IT WAS REPORTED THAT THE CABLE CUTTER WITH TRIGGER GRIP HANDLE BROKE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22435786 ↗MalfunctionJun 10, 2025Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE THE BOLT AND A SCREW UNDID DURING THE CASE, WITHOUT THE PRODUCT BEING HIT/MESSED WITH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22176311 ↗MalfunctionMay 30, 2025Break; Device Slipped; Break; Device Slipped
IT WAS REPORTED THE CABLE CUTTER SCREW CAME OUT AND THE HANDLE IS LOOSE. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22116439 ↗MalfunctionMay 27, 2025Break; Break
IT WAS REPORTED THAT THE TRIGGER HANDLE BROKE FROM THE A24 CAMRON CAMPBELLS TRUNK STOCK. THERE WAS NO PATIENT INVOLVEMENT. THE EVENT OCCURRED POSTOPERATIVELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22089676 ↗MalfunctionMay 14, 2025Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE THE CABLE CUTTER WITH TRIGGER BROKE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22018698 ↗MalfunctionApr 22, 2025Break; Crack; Break; Crack
IT WAS REPORTED THAT USER WAS UNABLE TO STERILIZE/ASSEMBLE THE DEVICE DUE TO CHIPPING AND CRACKING.
Patient problems: Insufficient Information
MAUDE report 21882610 ↗MalfunctionFeb 6, 2025Break; Break
IT WAS REPORTED THAT DURING INSPECTION ON JANUARY 28, 2025, THE SIDE SCREW FELL OUT OF THE PISTOL GRIP CABLE CUTTER. IT WOULD NOT STAY TOGETHER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21325293 ↗MalfunctionJun 10, 2024Break; Device Slipped; Break; Device Slipped
IT WAS REPORTED THAT ON MAY 8, 2024, TRIGGER HANDLE F/CABLE CUTTER BROKE. THE PIN ON THE INSIDE DID NOT HOLD CORRECTLY AND THE TRIGGER WAS VERY LOOSE. IT IS UNKNOWN IF THERE WERE PATIENT AND PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) CABLE CUTTER W/TRIGGER HANDLE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: Insufficient Information
MAUDE report 19505108 ↗MalfunctionApr 10, 2024Break; Material Deformation; Break; Material Deformation
IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024. THE CABLE CUTTER WITH HANDLE WAS PUT ON IN A PATIENT AND TRIGGER BLACK HANDLE BROKE AND THE ACTUAL CUTTER OF METAL CUTTER WAS BENT AS WELL. PROCEDURE WAS COMPLETED WITH NO DELAY. PATIENT STATUS WAS GOOD. THIS REPORT IS FOR A CABLE CUTTER W/TRIGGER HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19081383 ↗MalfunctionFeb 21, 2024Break; Break
IT WAS REPORTED THAT ON FEBRUARY 7, 2024, THE HOLDING TAB CAME OUT AND DEVICE WAS MALFUNCTIONING. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) CABLE CUTTER W/TRIGGER HANDLE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18748057 ↗MalfunctionFeb 14, 2024Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, BROKEN PRODUCTS WERE FOUND WHEN AN ACCOUNT WAS INHERITED BY ANOTHER EMPLOYEE AFTER THE SALES REP HANDLING THE COMPLAINT LEFT. IT WAS NOT HOW/WHEN THEY WERE BROKEN AS THE SALES REP WAS THERE AT THE TIME THE PRODUCTS WERE BROKEN. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) CABLE CUTTER W/TRIGGER HANDLE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18702996 ↗MalfunctionJan 19, 2024Break; Device Slipped; Device-Device Incompatibility; Break; Device Slipped; Device-Device Incompatibility
IT WAS REPORTED THAT ON JANUARY 4, 2024, THE ORTHOPEDIC CABLE CUTTER WAS FOUND TO BE BROKEN IN THE SET UPON INSPECTION AFTER DECONTAMINATION. NO ISSUES OCCURRED DURING A CASE. THE SILVER TRIGGER GRIP WAS FOUND TO BE LOOSE AND DID NOT ENGAGE THE CUTTING MECHANISM. THIS REPORT INVOLVES ONE CABLE CUTTER W/TRIGGER HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18545887 ↗MalfunctionJan 17, 2024Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKEN. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT IMPACT. THIS REPORT IS FOR ONE (1) CABLE CUTTER W/TRIGGER HANDLE THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18526979 ↗MalfunctionDec 27, 2023Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING THE WEEK OF (B)(6) 2023, A TRAY WAS OPENED WITH THE INTENTION TO USE THE DEVICE AND THE TRIGGER/HANDLE OF THE CUTTER FELL OUT COMPLETELY. IT APPEARED THAT THE TWO-PIECE THREADED PIN THAT HOLDS THE HANDLE IN PLACE WAS BROKEN/MISSING. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE CABLE CUTTER W/TRIGGER HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: Insufficient Information
MAUDE report 18401304 ↗MalfunctionAug 25, 2023Break; Break
A TOTAL JOINT REPLACEMENT WAS BEING PERFORMED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17624070 ↗MalfunctionJul 26, 2023Break; Break
IT WAS REPORTED THAT ON (B)(6) 2023, THE COMPONENT THAT HOLDS THE TRIGGER HANDLE OF THE CABLE CUTTER IN QUESTION IS BROKEN AND MISSING. THE EVENT WAS DISCOVERED DURING STERILE PROCESSING. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A CABLE CUTTER W/TRIGGER HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17396463 ↗MalfunctionFeb 2, 2023Break; Break
IT WAS REPORTED THAT ON (B)(6) 2023, DURING INTRA-OP CUTTER BROKE DURING SURGERY. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY. IT WAS UNKNOWN IF THERE WAS ANY FRAGMENTS WERE GENERATED. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) CABLE CUTTER W/TRIGGER HANDLE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16283721 ↗MalfunctionSep 30, 2022Break; Break
IT WAS REPORTED THAT ON (B)(6) 2022, THE CABLE CUTTER WAS BROKEN DURING SURGERY. AN OLD CUTTER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A DELAY OF 2 MINUTES AS A RESULT OF THIS EVENT. THIS REPORT INVOLVES ONE CABLE CUTTER W/TRIGGER HANDLE. THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15519342 ↗
Other CUTTER, WIRE devices
- NA 03.607.513Synthes GmbH · CUTTER, WIRE35 reports
- NA 388.72Synthes GmbH · CUTTER, WIRE29 reports
- NA 03.221.008Synthes GmbH · CUTTER, WIRE11 reports
- NA 391.93Synthes GmbH · CUTTER, WIRE9 reports
- NA 391.906Synthes GmbH · CUTTER, WIRE8 reports
- NA 391.771Synthes GmbH · CUTTER, WIRE8 reports
- NA 391.905Synthes GmbH · CUTTER, WIRE7 reports
- Tecomet AR-9938-11Tecomet Inc. · Cutter, Wire6 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page