NA 388.621Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10705034773643), received between Sep 3, 2019 and Jan 7, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Calibration Problem” (7 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 7, 2026Mechanical Problem; Material Integrity Problem

  IT WAS REPORTED THAT WHEN SURGEON ATTEMPTED TO TIGHTEN SCREW, THE HANDLE BROKE AND FELL APART. THERE WAS NO SURGICAL DELAY WAS REPORTED. THERE WAS NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23996030 ↗
• MalfunctionJun 9, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE WOOD HANDLE FOR USS BROKE DURING THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS GENERATION OF FRAGMENTS WHICH WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22167319 ↗
• MalfunctionFeb 4, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2025, A FELLOW WAS INSERTING A SCREW, WHEN THE HOLDER HANDLE BROKE AND ¿CRUMBLED.¿ THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21304105 ↗
• MalfunctionMay 17, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED ON (B)(6) 2024, THE USS SWIZEL STICK DRIVER BROKE INTO MULTIPLE PIECES INTRAOPERATIVELY. THE DEVICE WAS BROKEN BEYOND REPAIR AND THE PRODUCT WAS DISCARDED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO ADDITIONAL MEDICAL INTERVENTION REQUIRED. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR ONE HANDLE FOR HOOK OR SCREW HOLDER THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19344900 ↗
• MalfunctionApr 10, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, THE USS WOODEN SCREWDRIVER HANDLE BROKE DURING A POSTERIOR SPINAL FUSION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THIS REPORT IS FOR A HANDLE FOR HOOK OR SCREW HOLDER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19080273 ↗
• MalfunctionJan 29, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, ONE (1) LOCKING BOLT MEASURING DEVICE FOR TROCHANTERIC FIXATION NAILS WAS FOUND TO BE BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9641670 ↗
• MalfunctionNov 1, 2019Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, EIGHT (8) TORQUE LIMITING HANDLES WERE FOUND TO HAVE FAILED IN CALIBRATION DURING A REVERSE LOGISTICS AUDIT OF RETURNED DEVICES. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) TORQUE LIMITING HANDLE/QUICK RELEASE-6MM HEX COUPLING. THIS IS REPORT 4 OF 8 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9265619 ↗
• MalfunctionNov 1, 2019Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, EIGHT (8) TORQUE LIMITING HANDLES WERE FOUND TO HAVE FAILED IN CALIBRATION DURING A REVERSE LOGISTICS AUDIT OF RETURNED DEVICES. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) TORQUE LIMITING HANDLE/QUICK RELEASE-6MM HEX COUPLING. THIS IS REPORT 6 OF 8 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9265609 ↗
• MalfunctionOct 18, 2019Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, EIGHT (8) TORQUE LIMITING HANDLES WERE FOUND TO HAVE FAILED IN CALIBRATION DURING A REVERSE LOGISTICS AUDIT OF RETURNED DEVICES. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) TORQUE LIMITING HANDLE/QUICK RELEASE-6MM HEX COUPLING. THIS IS REPORT 8 OF 8 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9209563 ↗
• MalfunctionOct 18, 2019Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, EIGHT (8) TORQUE LIMITING HANDLES WERE FOUND TO HAVE FAILED IN CALIBRATION DURING A REVERSE LOGISTICS AUDIT OF RETURNED DEVICES. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) TORQUE LIMITING HANDLE/QUICK RELEASE-6MM HEX COUPLING. THIS IS REPORT 4 OF 8 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9209560 ↗
• MalfunctionOct 9, 2019Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, EIGHT (8) TORQUE LIMITING HANDLES WERE FOUND TO HAVE FAILED IN CALIBRATION DURING A REVERSE LOGISTICS AUDIT OF RETURNED DEVICES. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) TORQUE LIMITING HANDLE/QUICK RELEASE-6MM HEX COUPLING. THIS IS REPORT 7 OF 8 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9172946 ↗
• MalfunctionOct 9, 2019Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, EIGHT (8) TORQUE LIMITING HANDLES WERE FOUND TO HAVE FAILED IN CALIBRATION DURING A REVERSE LOGISTICS AUDIT OF RETURNED DEVICES. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) TORQUE LIMITING HANDLE/QUICK RELEASE-6MM HEX COUPLING. THIS IS REPORT 5 OF 8 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9172736 ↗
• MalfunctionOct 9, 2019Device Difficult to Program or Calibrate; Calibration Problem; Device Difficult to Program or Calibrate; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, EIGHT (8) TORQUE LIMITING HANDLES WERE FOUND TO HAVE FAILED IN CALIBRATION DURING A REVERSE LOGISTICS AUDIT OF RETURNED DEVICES. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) TORQUE LIMITING HANDLE/QUICK RELEASE-6MM HEX COUPLING. THIS IS REPORT 3 OF 8 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9172496 ↗
• MalfunctionSep 3, 2019Break; Break

  LIBERTAS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE HANDLE FOR HOOK OR SCREW HOLDER WAS FOUND TO BE BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE.   THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8956609 ↗