NA SD03.505.006Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887587074221), received between Aug 27, 2020 and Aug 27, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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.

• MalfunctionAug 27, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF A RIB FRACTURE ON (B)(6) 2020, THE HANDLE FOR 90 DEGREES SCREWDRIVER AND ADAPTOR FOR THE 90 DEGREES SCREWDRIVER BOUND UP TOGETHER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE MANUAL 90 DEGREE SCREWDRIVER. THERE WAS A TEN (10) MINUTES SURGICAL DELAY REPORTED. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) 90 DEGREE SCREWDRIVER BPD ADAPTER. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10463448 ↗