NA 03.110.002Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982071828), received between Mar 6, 2017 and Mar 20, 2017 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 20, 2017Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2017, THE TORQUE LIMITING ATTACHMENT 1.2NM BROKE INTO TWO (2) PIECES AS THE SURGEON WAS BACKING OUT A SCREW FROM A PLATE. THE AGE OF THE DEVICE IS UNKNOWN. IT WAS STATED THAT THE SURGEON WAS APPLYING THE CORRECT AMOUNT OF PRESSURE AT THE TIME OF BREAKAGE. NO PIECES FELL INTO THE PATIENT¿S WOUND AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING AN ALTERNATIVE DEVICE. THERE WAS NO SURGICAL TIME DELAY AND THE PATIENT OUTCOME WAS REPORTED AS STABLE. CONCOMITANT DEVICES REPORTED: SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1), PLATE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6419554 ↗
• MalfunctionMar 6, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A TORQUE LIMITING ATTACHMENT CAME APART DURING A DISTAL TIBIAL ANKLE SURGERY ON (B)(6) 2017. DURING THE PROCEDURE, THE TORQUE LIMITING ATTACHMENT, WHICH WAS POWERED BY A COMPETITOR¿S DRILL, CAME APART INTO THREE PIECES AND ONE SPRING. THERE WAS NO REPORT OF BREAKAGE OR FRAGMENTATION. THE SURGEON FINISHED IMPLANTING THE SCREWS BY HAND. THERE WAS NO SURGICAL DELAY OR PATIENT HARM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME WAS STABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN COMPETITOR¿S DRILL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY: ONE) THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6380871 ↗