FDA Adverse Event
Malfunction
Summary report: N
BONE MILL HANDPIECE CABLE
MDR report key: 2702394
·
Received August 9, 2012
Report
- Report Number
- 1811755-2012-03048
- Event Type
- Malfunction
- Date Received
- August 9, 2012
- Date of Event
- July 20, 2012
- Report Date
- July 20, 2012
- Manufacturer
- STRYKER INSTRUMENTS, INSTRUMENTS DIV.
- Product Code
- HWE
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RECEIVED FOR EVAL; ADD'L INFO WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
THE BONE MILL HANDPIECE CABLE WAS SENT FOR SERVICE AND IT WAS NOTED DURING PERFORMANCE TESTING THAT THERE IS A CUT IN A THE CABLE AND EXPOSED BARE WIRES ARE SHOWING. NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BONE MILL HANDPIECE CABLE | HWE | STRYKER INSTRUMENTS, INSTRUMENTS DIV. | 11145 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |