NA 181-65-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862038661), received between Mar 8, 2021 and Nov 21, 2022 — classified as 3 malfunctions.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED DURING SURGICAL USE, THE SURGEON PERFORMED THA PROCEDURE AND DURING THIS SURGERY, SURGEON ENCOUNTERED A INCIDENT THAT A TIP OF DRIVER WAS DISASSEMBLED AND ALL PARTS EXCEPT FOR ONE SHAFT WAS RETRIEVED FROM SURGICAL FIELD AND OPERATION ROOM. USING THE IMAGING MACHINE, HE CHECKED IF A SHAFT WAS LEFT IN PATIENT BODY. AS A RESULT, THERE WAS NOT FOUND OUT A SHAFT IN PATIENT BODY. THERE WAS A 31-45 MIN SURGICAL DELAY/PROLONGATION. THERE WAS NO ADVERSE EVENT AS A RESULT OF THE SURGICAL DELAY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGE RECEIVED. SALES REP WAS UNABLE TO OBTAIN X-RAY. DEVICE IS AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15833537 ↗
• MalfunctionJan 10, 2022Break; Break

  AS REPORTED, THE TIP OF 6.5 HEX DRIVE BROKE OFF AT THE END OF THE SCREWDRIVER HEAD. THE SURGICAL SITE WAS CHECKED, AND NO INSTRUMENTATION WAS LEFT IN THE SURGICAL FIELD, IT WAS CONFIRMED CLEAN BY SURGEONS. THIS EVENT CAUSED NO DELAY AND THE PROCEDURE PROCEEDED WITH NO ISSUES. PATIENT IS CURRENTLY IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13206145 ↗
• MalfunctionMar 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE TIP OF THE DRIVER SHAFT BROKE OFF DURING TIGHTENING OF THE HIP SCREW. THIS CAUSED NO DELAY, PATIENT WAS NOT AFFECTED, AND THIS SURGERY CONTINUED AS NORMAL. PATIENT IS IN STABLE CONDITION. THE DEVICE WILL BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11438848 ↗