NA 314.411.96Recalls & reported problems
Synthes GmbH · 1.3MM CRUCIFORM SCREWDRIVER BLADE WITH HOLDING SLEEVE · 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 10886982188809), received between Jul 1, 2019 and Aug 18, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break3
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Patient Involvement2
Recent adverse event reports
The 4 most recent of 4 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 22826714 ↗MalfunctionJun 18, 2021Break; Break
IT WAS REPORTED THAT, THE 1.3 CRUC SCRDRIVER BLADE HOLDING SLEEVE AND SCRDRIVERSHAFT-CRUCIF 1 W/HOLD-SLEEVE GR WERE FOUND BROKEN. NO PATIENT CONSEQUENCES NOTED. THIS REPORT IS FOR (1) 1.3MM CRUCIFORM SCREWDRIVER BLADE WITH HOLDING SLEEVE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12028553 ↗MalfunctionAug 7, 2019Break; Break
IT WAS REPORTED ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET AT FSL (B)(4) SITE, THE CRUCIFORM SCREWDRIVER BLADE WITH HOLDING SLEEVE WAS OBSERVED BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 8871392 ↗MalfunctionJul 1, 2019Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE INSPECTION, OF A LOANER SET, IT WAS DISCOVERED THAT 314.411.96, SCREWDRIVER BLADE, LOT NUMBER L735311 1.3MM CRUCIFORM 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 8749927 ↗
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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