FDA Adverse Event
Malfunction
Summary report: N
LOCKING SCREW
MDR report key: 1062280
·
Received June 17, 2008
Report
- Report Number
- 8031020-2008-00042
- Event Type
- Malfunction
- Date Received
- June 17, 2008
- Date of Event
- April 28, 2008
- Report Date
- May 20, 2008
- Manufacturer
- STRYKER OSTEOSYNTHESIS
- Product Code
- HWC
- PMA / PMN Number
- K050512
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFO HAS BEEN REQUESTED AND IF REC'D, WILL BE SUPPLIED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "STARTED A 93MM LOCKING SCREW BY HAND AND THEN POWERED IN AND IT DIDN'T SEAT ALL THE WAY DOWN. WHEN BACKING OUT THE SCREW, IT STRIP AND THE METAL SHAVINGS WENT EVERYWHERE. WE TRIED PUTTING ANOTHER ONE IN BY HAND, AND IT DID SEAL ALL THE WAY DOWN BUT THE SCREW HEAD SNAPPED OFF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LOCKING SCREW | IMPLANT | HWC | STRYKER OSTEOSYNTHESIS | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR | Other |