NA 03.118.015Recalls & reported problems
Synthes GmbH · 2.8MM COMPRESSION WIRE 15MM THREAD/200MM LENGTH · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982073419), received between Mar 5, 2024 and Mar 5, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (2 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
- Material Deformation2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 5, 2024Material Deformation; Material Deformation
IT WAS REPORTED THAT ON (B)(6) 2024, UPON INSPECTION OF PANS WHILE PROCESSING PRIOR TO SURGERY, 2 OF THE COMPRESSION WIRES WERE FOUND TO BE BENT/WARPED. IT COULD NOT BE USED FOR SURGERY. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE 2.8 COMP WIRE 15 THREAD/200 LENGTH FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18840446 ↗MalfunctionMar 5, 2024Material Deformation; Material Deformation
IT WAS REPORTED THAT ON (B)(4)2024, UPON INSPECTION OF PANS WHILE PROCESSING PRIOR TO SURGERY, 2 OF THE COMPRESSION WIRES WERE FOUND TO BE BENT/WARPED. IT COULD NOT BE USED FOR SURGERY. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE 2.8 COMP WIRE 15 THREAD/200 LENGTH FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18839819 ↗
Other INSTRUMENT, COMPRESSION devices
- ATTUNE 2545-01-042Depuy (Ireland) · INSTRUMENT, COMPRESSION153 reports
- ATTUNE 2545-11-041Depuy (Ireland) · INSTRUMENT, COMPRESSION78 reports
- ATTUNE 2545-05-550Depuy (Ireland) · INSTRUMENT, COMPRESSION54 reports
- ATTUNE 2545-05-551Depuy (Ireland) · INSTRUMENT, COMPRESSION34 reports
- NA 03.111.021Synthes GmbH · INSTRUMENT, COMPRESSION32 reports
- ATTUNE 2545-05-552Depuy (Ireland) · INSTRUMENT, COMPRESSION27 reports
- NA 03.211.400Synthes GmbH · INSTRUMENT, COMPRESSION25 reports
- VIPER PRIME 286750083Medos International Sàrl · INSTRUMENT, COMPRESSION18 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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