FDA Adverse Event
Malfunction
Summary report: N
SET SCREWDRIVER, FLEXIBLE SHAFT 4 MM
MDR report key: 1946354
·
Received December 10, 2010
Report
- Report Number
- 9610622-2010-00540
- Event Type
- Malfunction
- Date Received
- December 10, 2010
- Date of Event
- December 1, 2010
- Report Date
- December 2, 2010
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- LXH
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NA
Description of Event or Problem · 1
THE HEAD OF THE CENTRAL STERILIZATION SERVICE, REPORTED IN HIS FAX THAT THE MANACLE RING AT THE SET SCREWDRIVER LEAD IS INTRAOPERATIVELY TORN OFF. A SUBSTITUTE INSTRUMENT WAS AVAILABLE AND THE DESIRED OPERATION RESULT COULD BE ACHIEVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SET SCREWDRIVER, FLEXIBLE SHAFT 4 MM | INSTRUMENT | LXH | STRYKER OSTEOSYNTHESIS KIEL | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |