NA 03.108.040Recalls & reported problems
Synthes GmbH · K-WIRE ADAPTOR FOR 2.8MM K-WIRES · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982071798), received between Apr 25, 2022 and Apr 25, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).
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
- Device-Device Incompatibility1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 25, 2022Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: THIS IS REPORT 3 OF 5 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN AUSTRALIA THAT DURING AN UNKNOWN SURGERY ON (B)(6)2022, IT WAS OBSERVED THAT TWO K-WIRE DEVICES JAMMED IN EACH GUIDE (03.108.001 AND 03.108.002) AND THE PLATE DEVICE WAS USED AS A GUIDE INSTEAD. IT WAS FURTHER REPORTED THAT DURING REMOVAL OF WIRES LATER, THE EXTENDER ALSO APPEARED DAMAGED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) ADAPT Ø2.8 F/LCP PAED-HIP PL3.5/5.0DEVICE. THIS COMPLAINT INVOLVES FIVE (5) DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14196556 ↗
Other TWISTER, WIRE devices
- Integra® Jarit® 121260Integra Lifesciences Production Corporation · TWISTER, WIRE1 report
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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