FDA Adverse Event
Malfunction
Summary report: N
DRILL, AO, STERILE 4,2X180 MM
MDR report key: 1958591
·
Received December 16, 2010
Report
- Report Number
- 9610622-2010-00572
- Event Type
- Malfunction
- Date Received
- December 16, 2010
- Date of Event
- December 13, 2010
- Report Date
- December 13, 2010
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- HBE
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
DEVICE WILL NOT BE RETURNED. IF THE DEVICE OR ADD'L INFO IS REC'D, IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
THE NURSE FROM THE HOSPITAL REPORTED BY PHONE TO THE QA MANAGER FROM STRYKER (B)(6), THE ALLEGE EVENT. THE LABEL ON THE DEVICE WAS NOT CORRECT. THE CATALOG NUMBER ON THE DRILL WAS LABELED W/O AN "S" WHICH WOULD INDICATE THAT THE DEVICE WAS NOT STERILE. THE DEVICE SHOULD BE STERILE AND SHOULD HAVE AN S.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DRILL, AO, STERILE 4,2X180 MM | INSTRUMENT | HBE | STRYKER OSTEOSYNTHESIS KIEL | NA | K185590 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |