NA 314.09Recalls & reported problems
Synthes GmbH · 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 10886982188489), received between Aug 26, 2021 and Nov 14, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Use of Device Problem” (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
- Use of Device Problem3
- Component Missing1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 14, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT ON (B)(6) 2025, STERILE PROCESSING DETERMINED THAT ITEMS WERE DAMAGED AND COULD NOT BE PUT BACK IN SETS. A SILICONE HANDLE HAD A KNIFE CUT THROUGH IT. HOLDING SLEEVES WERE MISSING THEIR SPRINGS AND NOT ABLE TO BE USED. SHORT RETENTION PINS HAD THE THREADED TIPS BROKEN OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23555374 ↗MalfunctionNov 14, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT ON (B)(6) 2025, STERILE PROCESSING DETERMINED THAT ITEMS WERE DAMAGED AND COULD NOT BE PUT BACK IN SETS. A SILICONE HANDLE HAD A KNIFE CUT THROUGH IT. HOLDING SLEEVES WERE MISSING THEIR SPRINGS AND NOT ABLE TO BE USED. SHORT RETENTION PINS HAD THE THREADED TIPS BROKEN OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23555373 ↗MalfunctionNov 14, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT ON (B)(6) 2025, STERILE PROCESSING DETERMINED THAT ITEMS WERE DAMAGED AND COULD NOT BE PUT BACK IN SETS. A SILICONE HANDLE HAD A KNIFE CUT THROUGH IT. HOLDING SLEEVES WERE MISSING THEIR SPRINGS AND NOT ABLE TO BE USED. SHORT RETENTION PINS HAD THE THREADED TIPS BROKEN OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23555372 ↗MalfunctionAug 26, 2021Component Missing; Component Missing
IT WAS REPORTED THAT ON UNKNOWN DATE, DURING ROUTINE INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT HOLDING SLEEVE WAS MISSING A COMPONENT. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR 1 HOLDING SLEEVE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12374925 ↗
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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