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
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
- DELTA XTEND 2307-92-003Depuy (Ireland) · SCREWDRIVER751 reports
- EXPEDIUM 279712400Medos International Sàrl · SCREWDRIVER551 reports
- NA 314.467Synthes GmbH · SCREWDRIVER498 reports
- N/A 5584111Medtronic Sofamor Danek, Inc. · SCREWDRIVER492 reports
- QUICKSET 2274-47-000Depuy (Ireland) · SCREWDRIVER487 reports
- NA 03.130.010Synthes GmbH · SCREWDRIVER1 recall422 reports
- QUICKSET 2274-63-000Depuy (Ireland) · SCREWDRIVER404 reports
- EVOS 71175072Smith & Nephew, Inc. · SCREWDRIVER336 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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