NA 02.221.085Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982275622), received between Oct 4, 2022 and Oct 4, 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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 4, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, WHILE INSERTING A 3.5 VA LOCKING SCREW INTO A VA PERIPROSTHETIC HOOK PLATE, THE 3.5 VA LOCKING SCREW DID NOT ENGAGE THE PLATE. THE SURGEON DECIDED TO LEAVE THE HOLE EMPTY AND PLACE ANOTHER SCREW IN A DIFFERENT HOLE. ADDITIONALLY, THE SURGEON ONLY CHOSE TO PUT ONE 3.5 VA LOCKING SCREW IN THE HEAD OF THE PLATE ALONG WITH 2 CABLES INSTEAD OF THE 2 RECOMMENDED. THE SURGEON ALSO STATED THAT THE 3.2MM DRILL BIT WAS DULL. HE WAS PLEASED WITH THE FIXATION AND THE SURGERY WAS SUCCESSFULLY COMPLETED. THERE WAS 5 MINS OF SURGICAL DELAY. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 3.5/4.5MM VA PPFX PROX FEMUR HOOK PL/SMALL/5HOLES/LEFT. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15537697 ↗