NA 311.005Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10887587035574), received between Jan 27, 2020 and Feb 6, 2023 — classified as 4 malfunctions.

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

• MalfunctionFeb 6, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023 THAT THE SCRUB NURSE WAS UNABLE TO LOAD THE SCREWDRIVER INTO THE HANDLE, THEY TRIED A DIFFERENT HANDLE BUT THE SCREWDRIVER WOULD NOT ENGAGE SO THEY TRIED THE ORIGINAL HANDLE WITH A NEW SCREWDRIVER AND THIS STILL WOULDN¿T ENGAGE. UPON TRYING A DIFFERENT SCREWDRIVER WITH A DIFFERENT HANDLE THESE ENGAGED AS THEY SHOULD. IT IS PRESUMED THE ORIGINAL HANDLE AND SCREWDRIVER SHAFT WERE BOTH FAULTY. THE SURGERY WAS COMPLETED IN A TIMELY MANNER AND THERE WERE NO OTHER COMPLICATIONS . THERE WAS NO PATIENT IMPACT AND THE PROCEDURE WAS NOT DUE TO THE FAILURE. THE PATIENT IS DOING WELL. THIS REPORT IS FOR ONE (1) HANDLE-SM W/HEX-COUPL. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16306542 ↗
• MalfunctionDec 2, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, DURING A PRE SURGERY TEST IT WAS NOTICED THAT THE SCREWDRIVER CAN NOT BE LOCKED IN THE HANDLE. THE SCREWDRIVER WAS TESTED IN ANOTHER HANDLE AND IT WORKED. ALLEGATION WAS ONLY AGAINST THE HANDLE AND NOT AGAINST THE SCREWDRIVER. PROCEDURE HAD NO IMPACT, AS ANOTHER HANDLE WAS USED TO PERFORM THE SURGERY. CONCOMITANT DEVICE REPORTED: MATRIXMIDFACE SCREWDRIVER BLADES (PART:03.503.202;LOT#:U373524; QUANTITY: 1). THIS REPORT IS FOR ONE (1) HANDLE-SM W/HEX-COUPLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12917862 ↗
• MalfunctionMay 19, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CHINA AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT AFTER AN UNKNOWN SURGERY THE DRIVER AND THE HANDLE COULD NOT BE DISASSEMBLE. THE SURGERY OUTCOME WAS UNKNOWN. THERE WERE NO PATIENT CONSEQUENCES. THIS COMPLAINT INVOLVES (1) DEVICE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10072477 ↗
• MalfunctionJan 27, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, THE SCREWDRIVER HANDLE WITH HEXAGONAL COUPLING FOR BONE FIXATION SYSTEM IS NOT LOCKING. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SCREWDRIVER HANDLE WITH HEX COUPLING-SMALL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9634857 ↗