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
- 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 391.93Synthes 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
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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