FDA Adverse Event
Malfunction
Summary report: N
HOLDING SLEEVE FOR SCREWDRIVERS FOR SCREWHEADS:
MDR report key: 2051567
·
Received February 22, 2011
Report
- Report Number
- 8031020-2011-00047
- Event Type
- Malfunction
- Date Received
- February 22, 2011
- Date of Event
- December 16, 2010
- Report Date
- December 17, 2010
- Manufacturer
- STRYKER OSTEOSYNTHESIS SELZACH
- Product Code
- LXH
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE WILL NOT BE RETURNED. IF THE DEVICE OR ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED, CAPTURE LOCKING MECHANISM JAMMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HOLDING SLEEVE FOR SCREWDRIVERS FOR SCREWHEADS: | INSTRUMENT | LXH | STRYKER OSTEOSYNTHESIS SELZACH | NA | M02874 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |