NA 219959Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886705007028), received between Dec 20, 2019 and Dec 20, 2019 — 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. How this data works · Data updated Oct 13, 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.

• MalfunctionDec 20, 2019Material Twisted/Bent; Material Twisted/Bent

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) PROCEDURE, IT WAS OBSERVED THAT THE TIP OF THEIR 30 MM MODULAR DRIVER BROKE OFF IN THE SCREW. IT WAS REPORTED THAT THE TIP WAS REMOVED FROM THE SCREW WITH NO FURTHER ISSUE AND NO DEBRIS WAS LEFT IN THE PATIENT. FURTHERMORE, DURING THE SAME CASE, IT WAS FOUND THAT THE TIP OF THEIR 35 MM MODULAR DRIVER WAS BENT. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE 35 MM DRIVER WITH NO PATIENT HARM, BUT THERE WAS A THREE MINUTE SURGICAL DELAY TO THE CASE. THE SALES REP COULD NOT PROVIDE LOT NUMBERS FOR THE DEVICES BUT STATED THAT THE DEVICES ARE OVER FIVE YEARS OLD AND HAVE SEEN HEAVY USE IN THE FIELD. THERE WAS A DELAY IN THE SURGICAL PROCEDURE. THERE WAS A SPARE DEVICE AVAILABLE FOR USE TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Not Applicable

  MAUDE report 9504688 ↗