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NA 391.90Recalls & reported problems

Synthes GmbH · SMALL WIRE CUTTER 160MM · Class 1

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982198389), received between Mar 27, 2017 and Sep 16, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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.

Most reported problems

Device problems

  • Break3

Patient problems

  • No Clinical Signs, Symptoms or Conditions2
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 16, 2022Break; Break

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TIP OF THE WIRE CUTTER CHIPPED OFF. THE ITEM WAS BROKEN INSIDE ITS PACKAGING WHILE IT WAS STILL SEALED. THERE WAS NO PATIENT INVOLVEMENT AS THIS WAS DISCOVERED BEFORE SURGERY. THIS REPORT INVOLVES ONE SMALL WIRE CUTTER 160MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15440409 ↗
  • MalfunctionMar 3, 2022Break; Break

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SURGEON ADVISED THAT THE SMALL WIRE CUTTER 160MM WAS NOT BROKEN DURING USE. WHEN HE WENT TO USE IT FOR ANOTHER PROCEDURE (AFTER BEING CLEANED/RE-AUTOCLAVED), IT WAS THEN THAT THE ISSUE WAS NOTED. PROCEDURE OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES ONE(1) DEVICE SMALL WIRE CUTTER 160MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13661845 ↗
  • MalfunctionMar 27, 2017Break; Break

    IT WAS REPORTED DURING A FRACTURE REPAIR OF A DOG THAT THE TIPS OF A CUTTING INSTRUMENT SHATTERED. THE SURGEON WAS ATTEMPTING TO REMOVE A WIRE THAT HAD NOT FASTENED THE WAY THE SURGEON WANTED IT TO. AS THE SURGEON WAS CUTTING THE WIRE THE TIPS OF THE CUTTING INSTRUMENT SHATTERED. NO FRAGMENTS WERE LEFT BEHIND IN THE ANIMAL. INTRAOPERATIVE X-RAYS WERE TAKEN TO ENSURE NO FRAGMENTS REMAINED. THE ANIMAL WAS STABLE AFTER SURGERY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6438068 ↗

Other CUTTER, WIRE devices

All CUTTER, WIRE devices →

Sources and updates

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