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NA 314.26Recalls & reported problems

Synthes GmbH · LARGE HEXAGONAL SCREWDRIVER LONG · Class 1

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
6
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982188724), received between Aug 18, 2020 and Mar 28, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (3 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 2 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Material Twisted/Bent3
  • Material Integrity Problem2
  • Contamination /Decontamination Problem1
  • Corroded1

Patient problems

  • No Clinical Signs, Symptoms or Conditions4
  • No Consequences Or Impact To Patient2

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 28, 2025Material Twisted/Bent; Material Twisted/Bent

    IT WAS REPORTED THAT ON AN UNKNOWN DATE THE SCREWDRIVERS WERE FOUND STRIPPED AND TOMMY BAR BEING BENT. SD03.127.007 & 008 WON¿T CONNECT PLATE. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21720547 ↗
  • MalfunctionMar 28, 2025Material Twisted/Bent; Material Twisted/Bent

    IT WAS REPORTED THAT ON AN UNKNOWN DATE THE SCREWDRIVERS WERE FOUND STRIPPED AND TOMMY BAR BEING BENT. SD03.127.007 & 008 WON¿T CONNECT PLATE. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21720453 ↗
  • MalfunctionApr 13, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, THAT THE WOOD HANDLED INSTRUMENTS ARE LEAVING A STAIN/RESIDUE WHEN THEY ARE PEEL-PACKED AND STERILIZED. THERE WERE NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES FOURTEEN (14) DEVICES. THIS REPORT IS FOR ONE (1) LARGE HEXAGONAL SCREWDRIVER LONG. THIS IS REPORT 2 OF 14 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16738294 ↗
  • MalfunctionJul 22, 2021Corroded; Material Twisted/Bent; Corroded; Material Twisted/Bent

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SCREWDRIVER WAS SHOWING SIGNS OF OXIDATION AND WEAR. THIS REPORT IS FOR A SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12211269 ↗
  • MalfunctionAug 18, 2020Material Integrity Problem; Material Integrity Problem

    IT WAS REPORTED THAT ON (B)(6) 2020, THE STERILE PROCESSING DEPARTMENT (SPD) REPORTED THAT THE TWO (92) LARGE HEXAGONAL SCREWDRIVERS WERE FOUND TO HAVE DAMAGED HANDLES. THERE IS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES 2 DEVICES. THIS REPORT IS FOR (1) LARGE HEXAGONAL SCREWDRIVER LONG. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10422296 ↗
  • MalfunctionAug 18, 2020Material Integrity Problem; Material Integrity Problem

    IT WAS REPORTED THAT ON (B)(6) 2020, THE STERILE PROCESSING DEPARTMENT (SPD) REPORTED THAT THE TWO (92) LARGE HEXAGONAL SCREWDRIVERS WERE FOUND TO HAVE DAMAGED HANDLES. THERE IS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES 2 DEVICES. THIS REPORT IS FOR (1) LARGE HEXAGONAL SCREWDRIVER LONG. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10422290 ↗

Other SCREWDRIVER devices

All SCREWDRIVER devices →

Sources and updates

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