PROFILE 230525Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886705010509), received between Jan 14, 2019 and Jan 14, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Migration” (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.

• MalfunctionJan 14, 2019Migration; Migration

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE TIP OF THE CUSTOMER'S HEX DRIVER, 4.0 BECAME STUCK IN THE HEAD OF THE SCREW UPON INSERTION. WHEN THE SURGEON REMOVED THE DRIVER AFTER INSERTING THE SCREW, THE SCREW CAME OUT AT THE SAME TIME. THE SURGEON USED ANOTHER LIKE DEVICE WITH ANOTHER SCREW IN THE SAME BONE TUNNEL WITH NO PATIENT CONSEQUENCES OR DELAYS. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8245586 ↗