FDA Adverse Event
Malfunction
Summary report: N
REAMER SHAFT, MOD, TRINKLE 8.0X284 MM
MDR report key: 2471485
·
Received February 13, 2012
Report
- Report Number
- 9610622-2012-00077
- Event Type
- Malfunction
- Date Received
- February 13, 2012
- Date of Event
- January 26, 2012
- Report Date
- January 27, 2012
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- HWE
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL LOT # K130108. ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
DURING THE SURGERY, THE REAMER SHAFTS COULD NOT BE ASSEMBLED WITH THE REAMER HEAD. A BACKUP DEVICE WAS USED AND THERE WAS NO ADVERSE OUTCOME TO THE PT OR THE USER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REAMER SHAFT, MOD, TRINKLE 8.0X284 MM | INSTRUMENT | HWE | STRYKER OSTEOSYNTHESIS KIEL | NA | K749052 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |