NA 03.505.006Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10887587013329), received between Sep 2, 2020 and Mar 5, 2024 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 5, 2024Break; Break

  IT WAS REPORTED THAT ON 19-FEBRUARY-2024, THE COLLAR OF THE PRODUCT IN QUESTION BROKE OFF. THERE WERE NO PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A DRIVESHAFT FOR SCREWDRIVER 90°. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18836048 ↗
• MalfunctionNov 23, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022 THE AXEL AND SHAFT OF THE SCREWDRIVER IN QUESTION ARE STUCK TOGETHER. THERE WAS NO REPORTED PATIENT INTERACTION, EVENT OCCURRED POST-OP. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A DRIVESHAFT FOR SCREWDRIVER 90°. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15854702 ↗
• MalfunctionOct 20, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, THE SCREWDRIVER BLADES THAT ARE SELF-RETAINING NO LONGER HOLD A SCREW. THE 90 DEGREE SCREWDRIVER SHAFT THAT INSERTS IS RUINED AND THE END OF IT HAS FRAYING METAL PARTS. THIS WAS DISCOVERED DURING PRE-OP FIELD INSPECTION. THERE WAS NO CONSEQUENCE TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE SHAFT FOR 90° SCREWDRIVER. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15638101 ↗
• MalfunctionOct 20, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, THE SCREWDRIVER BLADES THAT ARE SELF-RETAINING NO LONGER HOLD A SCREW. THE 90 DEGREE SCREWDRIVER SHAFT THAT INSERTS IS RUINED AND THE END OF IT HAS FRAYING METAL PARTS. THIS WAS DISCOVERED DURING PRE-OP FIELD INSPECTION. THERE WAS NO CONSEQUENCE TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE SHAFT FOR 90° SCREWDRIVER. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15638094 ↗
• MalfunctionFeb 2, 2022Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE, DURING INSPECTION ITEMS ARE FOUND TO BE BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) DRIVESHAFT FOR SCREWDRIVER 90°. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13424031 ↗
• MalfunctionDec 8, 2021Material Twisted/Bent; Material Twisted/Bent

  THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12962746 ↗
• MalfunctionOct 28, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, 90 DEGREE ARM FOR 90 DEGREE SCREWDRIVER DOES NOT CLICK INTO A 90-DEGREE PIECE. THE PIECE IS THE INSERT OF THE 90-DEGREE ARM. THIS WAS DISCOVERED DURING AN INSPECTION WHILE CLEANING IT. THERE WAS NO PATIENT AND PROCEDURE INVOLVEMENT. THIS REPORT INVOLVES ONE (1) DRIVESHAFT FOR SCREWDRIVER 90°. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12713774 ↗
• MalfunctionSep 2, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, THE DRILL BIT KEEP COMING OUT TO THE 90 DEG DRILL, WE CHANGED 90 DEG DRILL BUT SAME THING HAPPENED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. CONCOMITANT DEVICE REPORTED: UNK, DRILL (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY # :1). THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR (1) DRIVESHAFT FOR SCREWDRIVER 90°. THIS IS REPORT 3 OF 4 (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10483923 ↗