NA 219203Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886705005475), received between Dec 19, 2018 and Apr 25, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 25, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGICAL PROCEDURE THE PROFILE HEXDRV CANN 3.5MM *EA DEVICE WAS BROKEN WHEN REMOVING AN OLD PROFILE SCREW. THERE WAS NO PATIENT HARM AND THE PROCEDURE WAS COMPLETED WITH MINIMAL ADDITIONAL TIME, BUT THE OLD SCREW COULD NOT BE REMOVED. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19179432 ↗
• MalfunctionDec 21, 2020Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN ESTONIA THAT DURING AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE ROFILE HEXDRV CANN 3.5MM DRIVER TIP WAS BROKEN. NO SURGICAL DELAY WAS REPORTED OR WHETHER A LIKE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11050700 ↗
• MalfunctionOct 21, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE HEX DRIVER MODULAR TIP 3.5 MM BROKE DURING AN UNKNOWN PROCEDURE. ANOTHER TRAY WAS USED TO COMPLETE THE PROCEDURE WITHOUT PATIENT CONSEQUENCE OR SURGICAL DELAY. THIS REPORT IS FOR ONE (1) HEX DRIVER MODULAR TIP 3.5 MM THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9215592 ↗
• MalfunctionDec 19, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ACL RECONSTRUCTION PROCEDURE THE CUSTOMER'S 3.5MM MODULAR HEX DRIVER TIP BROKE OFF WHILE INSERTING THE SCREW INTO THE BONE. THE SALES REP STATED THAT THE TIP OF THE SCREW WAS REMOVED FROM THE PATIENT WITH A GRASPER WITH NO PATIENT HARM OR DEBRIS LEFT BEHIND. THE CUSTOMER'S BIOINTRAFIX SHEATH TRIAL HAS FADED LASER LINES. THE CASE WAS COMPLETED WITH A DIFFERENT HEX DRIVER, BUT THIS SHEATH TRIAL WITH NO TIME DELAY. THE SALES REP WAS NOT PRESENT FOR THE CASE AND COULD NOT PROVIDE ANY ADDITIONAL INFORMATION. THE SALES REP COULD NOT PROVIDE LOT NUMBERS FOR THE DEVICES. THE DEVICES ARE BEING RETURNED FOR EVALUATION. 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 8178678 ↗