NA 209.695Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982150868), received between Jul 23, 2018 and Jul 23, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Twisted/Bent” (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.

• MalfunctionJul 23, 2018Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A HARDWARE REMOVAL AND REVISION PROCEDURE ON (B)(6) 2018 ONE (1) 7.3/95 MM CANNULATED SCREW BENT WHILE THE SURGEON WAS INSERTED IT INTO THE FEMORAL NECK AS A PROPHYLACTIC MEASURE. REPORTEDLY, THE SURGEON FELT THE DEVICE MALFUNCTION WAS RELATED TO THE PATIENT¿S DENSE CORTICAL BONE TISSUE. THE DAMAGED SCREW WAS NOT REMOVED. NO HARM WAS REPORTED TO THE PATIENT. NO SURGICAL DELAY WAS REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS REPORTED UNKNOWN. CONCOMITANT DEVICES REPORTED: WASHER 13.0MM (PART 219.99, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS TO CAPTURE THE BENT SCREW. THE NEED FOR THE HARDWARE REMOVAL AND REVISION PROCEDURE IS CAPTURED IN RELATED COMPLAINT (B)(4). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7711802 ↗