FDA Adverse Event
Malfunction
Summary report: N
BOX CHISEL
MDR report key: 1323896
·
Received December 8, 2008
Report
- Report Number
- 2249697-2008-00387
- Event Type
- Malfunction
- Date Received
- December 8, 2008
- Date of Event
- November 13, 2008
- Report Date
- November 14, 2008
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- KDG
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED, AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD DEVICE BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT. "AFTER CUTTING BOX FOR PS FEMUR DELTOR WAS TRYING TO REMOVE CHISEL & IT BROKE INTO TWO PIECES."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BOX CHISEL | INSTRUMENT | KDG | STRYKER ORTHOPAEDICS MAHWAH | NA | PYE09 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |