NA 314.411Recalls & reported problems
Synthes GmbH · 1.3MM 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 10887587037318), received between Jul 1, 2019 and Oct 18, 2023 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
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
- Break1
- Device-Device Incompatibility1
- Material Twisted/Bent1
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Patient Involvement1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 18, 2023Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON AN UNKNOWN DATE THE SURGEON COMPLAINED THAT THE FOLLOWING SCREWDRIVERS WERE WORN OUT AND NOT RETAINING THE SCREW WELL AND BELIEVES IT TO BE A MANUFACTURING ISSUE AND WANTS THEM REPLACED. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1)1.3 SCREWDRIVER BLADE HOLDING SLEEVE. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17956749 ↗MalfunctionApr 26, 2023No Apparent Adverse Event; No Apparent Adverse Event
DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: DEVICE WAS RECEIVED AS A BLIND UNIT FROM COLOMBIA ON JANUARY 19TH. THERE IS NO ALLEGATION REPORTED AGAINST THE DEVICE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 1.3MM SCREWDRIVER BLADE WITH HOLDING SLEEVE. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16816214 ↗MalfunctionJul 21, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2022 THE DEPTH GAUGE DID NOT SLIDE APPROPRIATELY AND SCREWDRIVER WITH HOLDING SLEEVE DID NOT HOLD SCREWS PROPERLY. THIS REPORT IS FOR ONE (1) 1.3MM SCREWDRIVER BLADE WITH HOLDING SLEEVE. THIS IS REPORT 1 OF 2 FOR COMPLAINT PC # (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15079925 ↗MalfunctionJul 1, 2019Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS DISCOVERED THAT 314.411, SCREWDRIVER BLADE, LOT NUMBER L003379 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 8750477 ↗
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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