FDA Adverse Event
Malfunction
Summary report: N
SCREWDRIVER, SELF-HOLDING, LONG SCREWDRIVER, SELF-
MDR report key: 2638166
·
Received June 26, 2012
Report
- Report Number
- 9610622-2012-00280
- Event Type
- Malfunction
- Date Received
- June 26, 2012
- Date of Event
- June 11, 2012
- Report Date
- June 11, 2012
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- HXX
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "THE TIP OF THE SCREWDRIVER BROKE OFF WHEN INSERTING THE SCN AND CAP INTO END OF SCN NAIL AND WAS LEFT IN PT. THE BROKEN TIP WAS STUCK IN THE END CAP THAT WAS PARTIALLY THREADED INTO NAIL AND COULD NOT BE REMOVED. SURGEON EXPRESSED CONCERN FOR ABILITY TO REMOVE NAIL IF END CAP COULD NOT BE REMOVED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SCREWDRIVER, SELF-HOLDING, LONG SCREWDRIVER, SELF- | INSTRUMENT | HXX | STRYKER OSTEOSYNTHESIS KIEL | NA | KMW3508021 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |