NA 702841Recalls & reported problems
Stryker GmbH · Screwdriver Hex 2.5mm Elastosil Handle · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540363817), received between Nov 19, 2020 and Nov 19, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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.
Most reported problems
Device problems
- Fracture1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 19, 2020Fracture; Fracture
THE CUSTOMER REPORTED THAT WHEN THE SURGEON WAS INSERTING A SCREW INTO A PATIENT THAT HAD A TIBIAL FRACTURE, THE TIP OF THE SCREWDRIVER BROKE OFF AND COULD NOT BE RETRIEVED FROM THE PATIENT. ADDITIONALLY REPORTED: THE SURGEON ATTEMPTED TO REMOVE THE PIECE OF THE SCREWDRIVER BUT DIDN¿T WANT TO COMPROMISE THE FRACTURE. TIP OF SCREWDRIVER WAS LEFT IN THE PATIENT. SURGICAL DELAY OF 5 MINUTES THE BONE WAS NOT HARD
Patient problems: Foreign Body In Patient
MAUDE report 10870075 ↗
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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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