FDA Adverse Event
Malfunction
Summary report: N
IM REAMER, AO FITTING 10,0X480 MM
MDR report key: 2062563
·
Received April 7, 2011
Report
- Report Number
- 9610622-2011-00152
- Event Type
- Malfunction
- Date Received
- April 7, 2011
- Date of Event
- March 17, 2011
- Report Date
- March 17, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- LXH
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
ADD'L INFO HAS BEEN REQUESTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADD'L INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
THE RISK MANAGER AT THE HOSPITAL REPORTED THAT DURING A TOTAL HIP SURGERY, THE DEVICE BROKE AND GOT STUCK IN THE PT'S FEMUR. THERE WAS NO DELAY IN SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IM REAMER, AO FITTING 10,0X480 MM | INSTRUMENT | LXH | STRYKER OSTEOSYNTHESIS KIEL | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |