FDA Adverse Event
Malfunction
Summary report: N
IM REAMER, AO FITTING 11,0X480 MM
MDR report key: 2140571
·
Received June 16, 2011
Report
- Report Number
- 9610622-2011-00265
- Event Type
- Malfunction
- Date Received
- June 16, 2011
- Date of Event
- June 1, 2011
- Report Date
- June 3, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- LXH
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
IT IS NOT KNOWN AT THIS TIME IF THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
THE PURCHASING MANAGER AT THE HOSPITAL REPORTED TO SALE REP THAT DURING A SURGERY, THE DEVICE BROKE IN 2 PIECES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IM REAMER, AO FITTING 11,0X480 MM | INSTRUMENT | LXH | STRYKER OSTEOSYNTHESIS KIEL | NA | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |