NA 214.560Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982154255), received between Apr 14, 2020 and Nov 20, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 20, 2020Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT FOR FRACTURE ORIF SURGERY. DURING THE SURGERY, 4.5 CANNULATED 60 MM SCREW WAS BEING SCREWED INTO PATIENT AND THREADING CAME OFF OF SCREW AND WENT TO A RIGHT ANGEL TO THE INTENDED TRAJECTORY AND EXITED PATIENT¿S SKIN. REMOVED SCREW FRAGMENT AND USE A DIFFERENT SCREW. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE THIS REPORT IS FOR (1) CANNSCR Ø4.5 SELF-DRILL L60/20 SST. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 10878828 ↗
• MalfunctionApr 14, 2020Crack; Crack

  IT WAS REPORTED ON AN UNKNOWN DATE THAT DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE LEFT ELBOW ON (B)(6) 2020, WHILE PLACING A SYNTHES 4.5 CANNULATED SCREW, THE SCREW DELAMINATED WHILE PLACING THE SCREW INTO THE PATIENT'S ELBOW. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9958913 ↗