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NA 313.932Recalls & reported problems

Synthes GmbH · LOW PROFILE NEURO SCRWDRVR BLD SLF-RETAIN/CRUCIFORM/MED/HXC · Class 1

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

Adverse event reports
4
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10887587037059), received between Nov 19, 2019 and May 10, 2024 — classified as 4 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: 1 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: 0 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 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Material Twisted/Bent3
  • Break1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2
  • No Consequences Or Impact To Patient2

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 10, 2024Material Twisted/Bent; Material Twisted/Bent

    IT WAS REPORTED THAT ON (B)(6) 2024, SURGEON WAS TRYING TO PLATE THE CRANIAL FLAP AND THE MATRIX NEURO SCREWS STARTED STRIPPING. SURGEON THOUGHT THAT EITHER THE SCREWS ARE DEFECTIVE OR THAT THE SCREW DRIVER SHAFTS ARE DEFECTIVE. SCREWS COLLECTED ALONG WITH THE SCREWDRIVER SHAFTS AND PUT IN AA SPECIMEN CUP TO BE SENT IN. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE SURGERY WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE LOW PROFILE NEURO SCREWDRIVER BLD SLF-RETAIN/CRUCIFORM/MED/HXC FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19286975 ↗
  • MalfunctionFeb 23, 2023Break; Break

    DEVICE REPORT FROM SINGAPORE REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6)2023, THE TIP OF THE SCREWDRIVER SHAFT IN QUESTION HAD BROKEN OFF. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR A LOW PROFILE NEURO SCREWDRIVER BLD SLF-RETAIN/CRUCIFORM/MED/HXC. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16431185 ↗
  • MalfunctionNov 19, 2019Material Twisted/Bent; Material Twisted/Bent

    IT WAS REPORTED ON AN UNKNOWN DATE, TWO (2) LOW PROFILE NEURO CRUCIFORM SCREWDRIVER BLADES WERE DAMAGED. IT IS UNKNOWN IF THERE WERE A PROCEDURE AND PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS IS 1 OF 2 FOR REPORT (B)(4).

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9342412 ↗
  • MalfunctionNov 19, 2019Material Twisted/Bent; Material Twisted/Bent

    IT WAS REPORTED ON AN UNKNOWN DATE, TWO (2) LOW PROFILE NEURO CRUCIFORM SCREWDRIVER BLADES WERE DAMAGED. IT IS UNKNOWN IF THERE WERE A PROCEDURE AND PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS IS 2 OF 2 FOR REPORT (B)(4).

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9342409 ↗

Other SCREWDRIVER devices

All SCREWDRIVER devices →

Sources and updates

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