FDA Adverse Event
Other
Summary report: N
IM REAMER SHAFT, AO FITTING, DOVETAIL 8,0X448MM
MDR report key: 1933128
·
Received December 10, 2010
Report
- Report Number
- 9610622-2010-00539
- Event Type
- Other
- Date Received
- December 10, 2010
- Date of Event
- December 1, 2010
- Report Date
- December 2, 2010
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- HTO
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THE DEVICE OR ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE SUBMITTED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
THE HEAD OF THE PURCHASING DEPARTMENT AND OPERATIONS, REPORTS THAT THE CENTRAL STERILIZATION DEPARTMENT HAS PROOF OF PROTEIN ON THE REAMER SHAFT AFTER IT WAS CLEANED AND STERILIZED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IM REAMER SHAFT, AO FITTING, DOVETAIL 8,0X448MM | INSTRUMENT | HTO | STRYKER OSTEOSYNTHESIS KIEL | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |