NA 313.991Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886982188335), received between Apr 4, 2018 and Jul 22, 2024 — classified as 9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, THE DENTED PROTECTION SLEEVE FOR FEMORAL NECK SYSTEM IS DENTED ON THE BOTTOM. ALSO, A CHIPPED CRUCIFORM SHAFT FOR SCREW REMOVAL SET AND A BENT PIN WRENCH FROM THE SCREW REMOVAL SET. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 1.0 CRUC SCREWDRIVER SFT, SELF-RETAINING. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19801604 ↗
• MalfunctionNov 13, 2023Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED VIA FEEDBACK FROM OR STAFF THAT THE T8 DRIVER REQUIRED REPLACING DUE TO DIFFICULTY ENGAGING WITH SCREW HEADS. IT WAS ALSO REPORTED THAT OTHER ITEMS NEEDED TO BE INSPECTED DURING THE SALES REP VISIT. AFTER INSPECTION FROM THE SALES REP WAS COMPLETED, OTHER ITEMS WERE FOUND REQUIRING REPLACEMENT DUE TO THEIR BEING WORN. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 1.0MM CRUCIFORM SCREWDRIVER SHAFT, SELF-RETAINING. THIS IS REPORT 9 OF 10 FOR (B)(4) .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18121703 ↗
• MalfunctionOct 4, 2023Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2023, THE TIP OF THE SCREW DRIVER WAS NOTED TO BE TWISTED AND WORN OUT. THIS WAS NOTED BY THE LOAN KIT TECHNICIAN DURING LOAN KIT INSPECTION. NO FURTHER DETAILS ARE AVAILABLE. THIS REPORT INVOLVES ONE 1.0MM CRUCIFORM SCREWDRIVER SHAFT, SELF-RETAINING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17868062 ↗
• MalfunctionApr 25, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, SCREW DRIVERS WERE STRIPPED. THERE WERE NO PATIENT OUTCOME/CONSEQUENCES. THIS REPORT IS FOR ONE (1)1.0 CRUC SCREWDRIVER SFT, SELF-RETAINING THIS IS REPORT 3 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16807293 ↗
• MalfunctionOct 25, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ITEM ATTACHMENTS WERE STUCK TOGETHER AND WOULDN'T SEPARATE. IT WAS UNKNOWN HOW THE ISSUE WAS DISCOVERED. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. CONCOMITANT DEVICE REPORTED: LARGE QUICK COUPLING - PTS DEVICE (PART# 338.49; LOT# UNKNOWN; QUANTITY: 1). THIS REPORT IS FOR ONE (1) 1.0MM CRUCIFORM SCREWDRIVER SHAFT, SELF-RETAINING THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12690635 ↗
• MalfunctionMar 30, 2021Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE, PATIENT UNDERWENT A HARDWARE REMOVAL OPERATION. THE TWO (2) DRIVERS, SCREWDRIVER SHAFT AND SCREWDRIVER WITH HOLDING SLEEVE HAD BROKEN DURING SCREW REMOVAL CASES, AND THAT A SCREWDRIVER HANDLE WAS NOT QUICK CONNECTING TO DRIVE SHAFTS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY AND NO FRAGMENTS WERE GENERATED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) 1.0 CRUC SCREWDRIVER SFT, SELF-RETAINING. THIS REPORT IS 2 OF 3 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11592216 ↗
• MalfunctionFeb 22, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING ROUTINE INSPECTION OF THE SCREW REMOVAL SET, A CONICAL EXTRACTION SCREW HAD STRIPPED THREADS, CRUCIFORM SCREWDRIVER SHAFT HAD A DAMAGED CRUCIFORM TIP, A LARGE HEXAGONAL SCREWDRIVER WITH T-HANDLE HAD WORN/ROUNDED HEX FLATS, AND A 2.4MM STARDRIVE SCREWDRIVER SHAFT HAD THE TEETH WORN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 1.0MM CRUCIFORM SCREWDRIVER SHAFT, SELF-RETAINING. THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8362302 ↗
• MalfunctionAug 31, 2018Break; Break

  THIS REPORT IS AGAINST USER FACILITY MEDWATCH NUMBER MW5078843, A COPY IS ATTACHED. THE ONLY INFORMATION CONTAINED IN THIS REPORT IS CORRECTION OR ADDITIONAL INFORMATION. CONCOMITANT DEVICE REPORTED: SCREW (PRODUCT# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) 1.0MM CRUCIFORM SCREWDRIVER SHAFT, SELF-RETAINING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7839362 ↗
• MalfunctionApr 4, 2018Break; Break

  IT WAS REPORTED THAT A SURGEON WAS PERFORMING A UNKNOWN SURGERY ON AN UNKNOWN DATE. WHILE TRYING TO REMOVE A 3.0MM CANNULATED SCREW WITH A 1.0 SCREWDRIVER, THE SCREWDRIVER BROKE. THE SURGEON SHOULD HAVE BE USING A 3.0 SCREWDRIVER FOR THIS SURGERY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7398009 ↗