NA SD03.505.005Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10887587071671), received between Aug 19, 2019 and Aug 18, 2023 — classified as 8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2023Break; Crack; Contamination /Decontamination Problem; Device-Device Incompatibility; Break; Crack; Contamination /Decontamination Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DEVICES IN QUESTION WERE FOUND TO BE UNABLE TO BE STERILIZED AND/OR ASSEMBLED. THE PRODUCTS WERE CHIPPING AND CRACKING, AND WERE UNABLE TO BE USED. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 90 DEGREE SCREWDRIVER T-HANDLE. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17573966 ↗
• MalfunctionAug 18, 2023Break; Crack; Contamination /Decontamination Problem; Device-Device Incompatibility; Break; Crack; Contamination /Decontamination Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DEVICES IN QUESTION WERE FOUND TO BE UNABLE TO BE STERILIZED AND/OR ASSEMBLED. THE PRODUCTS WERE CHIPPING AND CRACKING, AND WERE UNABLE TO BE USED. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 90 DEGREE SCREWDRIVER T-HANDLE. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17573962 ↗
• MalfunctionSep 24, 2020Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2020, AN INVENTORY CHECK OCCURRED AND MULTIPLE DEVICES INCLUDING A MESH CUTTER, RIGHT ANGLE BENDER, PLATE CUTTER, 90 DEGREE SCREWDRIVER T-HANDLE, HANDLE FOR 90° SCREWDRIVER, SHAFT FOR 90° SCREWDRIVER, AND MATRIXRIB SCREWDRIVER BLADE SELF-RETAINING F/90° SCREWDRIVER WERE FOUND WITH MALFUNCTIONS. WHEN TESTED, THE DEVICES WOULD NOT WORK PROPERLY; WOULD NOT TURN, HOLD SCREWS, AND SOME WERE STRIPPED. SOME INSTRUMENTS WERE BENT OR DULL. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10581669 ↗
• MalfunctionSep 24, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2020, AN INVENTORY CHECK OCCURRED AND MULTIPLE DEVICES INCLUDING A MESH CUTTER, RIGHT ANGLE BENDER, PLATE CUTTER, 90 DEGREE SCREWDRIVER T-HANDLE, HANDLE FOR 90° SCREWDRIVER, SHAFT FOR 90° SCREWDRIVER, AND MATRIXRIB SCREWDRIVER BLADE SELF-RETAINING F/90° SCREWDRIVER WERE FOUND WITH MALFUNCTIONS. WHEN TESTED, THE DEVICES WOULD NOT WORK PROPERLY; WOULD NOT TURN, HOLD SCREWS, AND SOME WERE STRIPPED. SOME INSTRUMENTS WERE BENT OR DULL. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10581224 ↗
• MalfunctionApr 3, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING A RIB FIXATION PROCEDURE, THE 90-DEGREE SCREWDRIVER WOULD NOT WORK WHEN INSERTING AN UNKNOWN SCREW. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE SURGEON USED A DIFFERENT UNKNOWN SCREWDRIVERS. THERE WAS A SURGICAL DELAY FIVE (5) MINUTES AND THERE WAS NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS IS REPORT 6 OF 6 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9922160 ↗
• MalfunctionApr 3, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING A RIB FIXATION PROCEDURE, THE 90-DEGREE SCREWDRIVER WOULD NOT WORK WHEN INSERTING AN UNKNOWN SCREW. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE SURGEON USED A DIFFERENT UNKNOWN SCREWDRIVERS. THERE WAS A SURGICAL DELAY FIVE (5) MINUTES AND THERE WAS NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS IS REPORT 3 OF 6 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9922104 ↗
• MalfunctionAug 19, 2019Material Twisted/Bent; Naturally Worn; Material Twisted/Bent; Naturally Worn

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING UNKNOWN INTRA-OPERATION SURGERY, THE SHAFT FOR 90 DEGREE SCREWDRIVER WOULD NOT PUT IN SCREW INTO THE PATIENT AND IT KEPT STRIPPING OUT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF 5 MINUTES USING A NEW SET OF DIFFERENT SCREWDRIVERS. PATIENT STATUS WAS UNKNOWN. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR ONE (1) 90 DEGREE SCREWDRIVER T-HANDLE. THIS REPORT IS 4 OF 10 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8908411 ↗
• MalfunctionAug 19, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING AN UNKNOWN INTRA-OPERATION SURGERY, THE SHAFT FOR 90 DEGREE SCREWDRIVERS WOULD NOT PUT IN SCREW INTO THE PATIENT AND IT KEPT STRIPPING OUT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF FIVE (5) MINUTES USING A NEW SET OF DIFFERENT SCREWDRIVERS. PATIENT STATUS WAS UNKNOWN. THIS COMPLAINT INVOLVES TOTAL THIRTEEN (13) DEVICES. THIS COMPLAINT (B)(4) CAPTURES 3 DEVICES, REMAINING 10 DEVICES ARE CAPTURED UNDER RELATED COMPLAINT (B)(4). THIS REPORT IS FOR ONE (1) 90 DEGREE SCREWDRIVER T-HANDLE. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8907432 ↗