NA 313.97.96Recalls & reported problems
Synthes GmbH · HOLDING SLEEVE FOR 2.4MM SCREWS · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982188304), received between Mar 6, 2019 and Oct 6, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (2 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
- Device-Device Incompatibility2
- Break1
- Device Slipped1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 6, 2023Device Slipped; Device-Device Incompatibility; Device Slipped; Device-Device Incompatibility
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE HOLDING SLEEVE FOR 2.4MM SCREWS WILL NOT LOCK INTO THE SCREWDRIVER BLADE; IT SLIDES OFF AND IS TOO LOOSE ON THE DRIVER. THIS IS OBSERVED DURING PRE-OP. THERE WAS NO PATIENT CONTACT, NO SURGICAL DELAY. THIS REPORT INVOLVES ONE HOLDING SLEEVE FOR 2.4MM SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4)
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17885972 ↗MalfunctionJun 28, 2022Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SPRINGS WERE BROKEN ON TWO HOLDING SLEEVE DEVICES. THERE WAS NO SURGEON OR PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 2 FOR (B)(4). THIS REPORT IS FOR A HOLD SLEEVE FOR 2.4 MM SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14841609 ↗MalfunctionMar 6, 2019Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE HOLDING SLEEVE FOR SCREWS DID NOT HOLD THE SCREWS. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. CONCOMITANT DEVICES REPORTED: UNKNOWN SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) HOLDING SLEEVE. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8397326 ↗
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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