NA 314.67.96Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10886982188991), received between Feb 21, 2017 and Aug 18, 2025 — classified as 11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT WHEN OPENING THE MOD HAND FOR A CASE DURING SURGERY, IT WAS NOTED THAT THE CAPTURES HAVE BEEN DAMAGED SO THEY NO LONGER WILL PICKUP THE CRUCIFORM SCREWS. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22826708 ↗
• MalfunctionAug 4, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SCREW CATCHER PART IS NOT GRABBING THE SCREWS AND IT DOES NOT ASSEMBLE. IT WAS DEFINITELY BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22698139 ↗
• MalfunctionMay 30, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024 DURING A PROCEDURE, A HOLDING SLEEVE WAS STUCK IN THE SHAFT OF THE DRIVER AS THE LITTLE LEGS SPREAD AND WE COULD NOT REMOVE IT DURING THE CASE. LEGS ARE NOW DAMAGED TO USE. THERE WAS A SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 1.5MM/2.0MM CRUCIFORM SCREWDRIVER BLD W/HOLDING SLV THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19431071 ↗
• MalfunctionOct 18, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE SURGEON COMPLAINED THAT THE FOLLOWING SCREWDRIVERS WERE WORN OUT AND NOT RETAINING THE SCREW WELL AND BELIEVES IT TO BE A MANUFACTURING ISSUE AND WANTS THEM REPLACED. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 1.5/2.0 CRUC SCREWDRIVER BLD HOLDING SLV THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17956745 ↗
• MalfunctionAug 16, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT THE SCREWDRIVERS ARE STRIPPED. THERE WAS NO PATIENT OUTCOME/CONSEQUENCES. THIS REPORT IS FOR ONE 1.5/2.0 CRUC SCREWDRIVER BLD HOLDING SLV. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15234313 ↗
• MalfunctionJul 28, 2022Break; Break

  IT WAS REPORTED THE DEPTH GAUGE WAS BROKEN. NO PATIENT CONSEQUENCES WERE REPORTED. THIS REPORT IS FOR A SCREWDRIVER. THIS IS REPORT 2 OF 5 FOR (B)(4). THIS COMPLAINT IS RELATED TO ANOTHER COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15120580 ↗
• MalfunctionOct 4, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING AN UNKNOWN PROCEDURE, THE SCREW DRIVER SHAFT WOULD NOT BE TAKEN OFF FROM THE HANDLE. THERE WAS NO SURGICAL DELAY. THE SURGERY WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) 1.5MM/2.0MM CRUCIFORM SCREWDRIVER BLD W/HOLDING SLV. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12569625 ↗
• MalfunctionOct 8, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE CRUCIFORM SCREWDRIVER BLADE WAS STUCK TO THE HANDLE WITH MINI QUICK COUPLING. IT WAS UNKNOWN WHEN THE ISSUE WAS DISCOVERED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 1.5MM/2.0MM CRUCIFORM SCREWDRIVER BLD W/HOLDING SLV. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9166074 ↗
• MalfunctionSep 19, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON UNKNOWN DATE, DURING ROUTINE CHECK, ALL OF THE SCREWDRIVER SHAFTS IN MODULAR HAND SET WERE STRIPPED AND UNABLE TO PLACE SCREWS. IF ATTEMPTED TO USE IN SURGERY, THESE SHAFTS WOULD BE USELESS. THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART# UNKNOWN, LOT # UNKNOWN, QUANTITY# UNKNOWN). THIS IS REPORT 1 FOR 2 (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9087757 ↗
• MalfunctionJul 1, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION, IT WAS DISCOVERED THAT THE SCREWDRIVER BLADE WITH HOLDING SLEEVE WAS BROKEN. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8750341 ↗
• MalfunctionFeb 21, 2017Bent; Bent

  IT WAS REPORTED THAT WHILE CLEANING A SYNTHES 1.5MM / 2.0MM CRUCIFORM SCREWDRIVER BLADE WITH HOLDING SLEEVE, THE STERILE PROCESSING STAFF WAS UNABLE TO REMOVE THE INNER "GRASPING" PART FROM THE OUTER TUBE. AFTER SEVERAL ATTEMPTS AND WITH THE AID OF A PAIR OF PLIERS, THE STAFF WAS ABLE TO SEPARATE THE PARTS AND REALIZED THAT THE INNER PORTION OF THE DEVICE WAS BENT. THE PIECES CAN NO LONGER BE ASSEMBLED. THERE WAS NO PATIENT INVOLVEMENT OR PROCEDURE ONGOING AND THE ISSUE WAS DISCOVERED OUTSIDE OF THE OPERATING ROOM. THIS COMPLAINT INVOLVES ONE (1) DEVICE: 1.5MM / 2.0MM CRUCIFORM SCREWDRIVER WITH ONE PART DATA. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6347986 ↗