NA 03.607.513Recalls & reported problems
Synthes GmbH · CABLE CUTTER · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Synthes cable cutter is a surgical instrument used to cut cerclage wire during orthopedic procedures. The 35 reports mostly describe the tool breaking or cracking, often mid-operation, with the cutting tip snapping off or the front cutter splitting into pieces, and once failing to cut at all. No deaths or injuries were reported, and most cases describe no patient impact. There are no recalls naming this device.
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
- 35
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 10886982080585), received between Jan 25, 2017 and Feb 6, 2026 — classified as 35 malfunctions.
The most frequently reported specific device problem is “Break” (32 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
- Break32
- Crack2
- Failure to Cut1
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions22
- No Known Impact Or Consequence To Patient7
- No Consequences Or Impact To Patient3
- No Patient Involvement2
- No Code Available1
Recent adverse event reports
The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 6, 2026Break
IT WAS REPORTED THAT THE CABLE FRONT CUTTER BROKE INTRAOPERATIVELY AND THEY HAD TO USE THE SIDE CUTTER INSTEAD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24279996 ↗MalfunctionDec 17, 2025Break; Break
IT WAS REPORTED THAT THE INSTRUMENT BROKE DURING SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23829089 ↗MalfunctionJun 26, 2025Break; Break
IT WAS REPORTED WHEN THE CERCLAGE WIRE WAS BEING CUT, THE CUTTING TIP FELL OFF/BROKE OFF. NO ADVERSE PATIENT CONSEQUENCES REPORTED, NO SURGICAL DELAY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22336530 ↗MalfunctionDec 9, 2024Break; Crack; Break; Crack
ADDITIONAL INFORMATION RECEIVED STATES THAT THIS WAS A PRE-OPERATIVE EVENT. THE INSTRUMENT WAS CRACKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20879173 ↗MalfunctionJun 12, 2024Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2024, THE TIP OF THE FRONT CUTTER IS BROKEN IN TWO PIECES. THERE WAS NO SURGICAL DELAY OR PATIENT HARM REPORTED. THIS REPORT IS FOR ONE (1) CABLE CUTTER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19521360 ↗MalfunctionJun 11, 2024Break; Break
IT WAS REPORTED THAT ON (B)(6) 2024, THE STERILE TECHNICIAN DISCOVERED THAT THE CABLE CUTTER WAS BROKEN. THIS REPORT INVOLVES ONE (1) CABLE CUTTER. THIS IS REPORT 2 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19508970 ↗MalfunctionMay 28, 2024Break; Break
IT WAS REPORTED THAT ON MARCH 7, 2024, THE ITEM WAS BROKEN. IT WAS DISCOVERED BY THE STERILE TECHNICIAN. NO FURTHER DETAILS WERE PROVIDED. THIS REPORT IS FOR A CABLE CUTTER. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19406435 ↗MalfunctionApr 22, 2024Break; Break
IT WAS REPORTED THAT THE INSTRUMENT IS DAMAGED/BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) CABLE CUTTER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19153276 ↗MalfunctionDec 12, 2023Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2023, THE TIP OF THE CABLE CUTTER IN QUESTION BROKE OFF. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A CABLE CUTTER. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18313151 ↗MalfunctionDec 5, 2023Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ITEM BROKE WHEN IT WAS BEING TESTED PREOPERATIVELY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE CABLE CUTTER. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18265138 ↗MalfunctionSep 29, 2022Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, A PORTION OF ONE OF THE CUTTER JAWS WAS BROKEN OFF. THIS WAS DISCOVERED DURING LOAN KIT INSPECTION. THERE WAS NO PATIENT INVOLVEMENT. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT INVOLVES ONE CABLE CUTTER. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15507947 ↗MalfunctionSep 15, 2022Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE CUTTING PLIERS BROKE. THERE WAS A SURGICAL DELAY OF FIFTEEN (15) MINUTES. THE METAL PARTS WERE REMOVED FROM THE SURGICAL WOUND. THIS REPORT INVOLVES ONE (1) CABLE CUTTER. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15427453 ↗MalfunctionAug 9, 2022Break; Break
DEVICE REPORT FROM GERMANY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, A PIECE OF THE HEAD OF THE CUTTER BROKE OFF WHILE CUTTING OFF CERCLAGE. THE OPERATION WAS COMPLETED WITHOUT ANY ADVERSE EFFECTS, THERE WAS NO PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A CABLE CUTTER. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15191358 ↗MalfunctionAug 9, 2022Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN KOREA, SOUTH AS FOLLOWS: IT WAS REPORTED ON JULY 14, 2022, THE PRODUCT WAS BROKEN IN THE PACKAGE. THIS REPORT IS FOR ONE (1) FRONT CUTTER THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15191091 ↗MalfunctionAug 3, 2022Crack; Crack
IT WAS REPORTED THAT ON AN UNKNOWN DATE, CRACK WAS FOUND IN CABLE CUTTER. IT IS UNKNOWN WHEN THE ISSUE WAS DISCOVERED. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) CABLE CUTTER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15157715 ↗MalfunctionMay 24, 2022Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE JAW OF CABLE CUTTER HAS SNAPPED OFF. THIS CASE HAS BEEN REPORTED BY THE LOAN KIT TECHNICIAN DURING LOAN KIT INSPECTION. IT HAS BEEN FORWARDED TO DEPUY ENGINEERING FOR ASSESSMENT. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER. THIS COMPLAINT INVOLVES ONE(1) DEVICE FRONT CUTTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14491452 ↗MalfunctionMar 24, 2022Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A CABLE SYSTEM FRONT CUTTER BROKE DURING CASE. THIS EVENT INVOLVES ONE (1) DEVICE. THIS IS REPORT 1 OF 1 FOR COMPLAINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13872239 ↗MalfunctionNov 23, 2021Break; Break
DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6), 2021, THE SURGEON FAILED TO FOLLOW INSTRUCTIONS TO USE THE FRONT CUTTER AND THE INSTRUMENT WAS DAMAGED. A PIECE NEAR THE NOSE OF THE INSTRUMENT CHIPPED OFF. DEVICE FRAGMENTS WERE EASILY REMOVED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A CABLE CUTTER. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12860892 ↗MalfunctionJun 25, 2021Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT, ONE SIDE OF THE JAW AREA HAS SNAPPED OF THE FRONT CUTTER. THIS CASE HAS BEEN REPORTED BY THE LOAN KIT TECHNICIAN DURING LOAN KIT INSPECTION. IT HAS BEEN FORWARDED TO DEPUY ENGINEERING FOR ASSESSMENT. THIS REPORT IS FOR ONE (1). THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12070196 ↗MalfunctionMay 25, 2021Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2021, THE TIP OF THE CABLE CUTTER BROKE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) CABLE CUTTER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11879294 ↗MalfunctionMar 18, 2021Break; Break
IT WAS REPORTED THAT ON UNKNOWN DATE, THE CABLE CUTTER WERE FOUND IN SET TO BE BROKEN. THIS WAS DISCOVERED WHEN THEY OPENED THE SET FOR THE CASE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) CABLE CUTTER. THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11516017 ↗MalfunctionMar 18, 2021Break; Break
IT WAS REPORTED THAT ON UNKNOWN DATE, THE CABLE CUTTER WERE FOUND IN SET TO BE BROKEN. THIS WAS DISCOVERED WHEN THEY OPENED THE SET FOR THE CASE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) CABLE CUTTER. THIS IS REPORT 2 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11516016 ↗MalfunctionSep 29, 2020Failure to Cut; Failure to Cut
DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2020, THAT THE PATIENT UNDERWENT FOR AN UNKNOWN SURGERY. DURING THE SURGERY, THE END OF THE CABLE CUTTER WAS WRAPPED OFF AND CABLE DID NOT CUT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 5 MINUTES DELAY. ALL FRAGMENTS WERE REMOVED WITHOUT ANY ADDITIONAL INTERVENTION. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: UNKNOWN CABLE (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY#: 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) CABLE CUTTER. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 10601108 ↗MalfunctionAug 20, 2019Break; Break
DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE CABLE CUTTER BROKE. THERE WAS NO REPORTED PATIENT CONSEQUENCE. THIS REPORT IS FOR A CABLE CUTTER. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8910360 ↗MalfunctionJan 31, 2019Material Integrity Problem; Material Integrity Problem
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TIP OF THE FRONT CUTTER BROKE AFTER TWO (2) MONTHS. IT WAS UNKNOWN WHEN WAS THE ISSUE WAS DISCOVERED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) CABLE CUTTER. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 8292673 ↗
Other CUTTER, WIRE devices
- NA 03.221.006Synthes GmbH · CUTTER, WIRE34 reports
- NA 388.72Synthes GmbH · CUTTER, WIRE29 reports
- NA 03.221.008Synthes GmbH · CUTTER, WIRE11 reports
- NA 391.93Synthes 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.
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