FDA Adverse Event
Injury
Summary report: N
BOX CHISEL
MDR report key: 1815404
·
Received August 19, 2010
Report
- Report Number
- 2249697-2010-01116
- Event Type
- Injury
- Date Received
- August 19, 2010
- Date of Event
- July 21, 2010
- Report Date
- July 27, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- KDG
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, 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. IF DEVICE OR ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "REP WAS FOLLOWING UP WITH (B)(6) ON (B)(6) 2010 AND DR MENTIONED THAT HE NOTICED DURING THE PROCEDURE, WHILE CUTTING THE FEMORAL BOX, THAT THERE WAS A CRACK IN THE MEDIAL FEMORAL CONDYLE (BONE). THIS WAS NOT DUE TO THE IMPLANTS, OR ANY OTHER STRYKER PRODUCT. DR RELATED IT TO A SMALL FEMUR AND HARD BONE. DR SPOKE TO REP AND BOTH DECIDED TO REPORT THE INCIDENT, JUST TO GET IT ON RECORD. USED 6.5 PARTIALLY THREADED SCREW TO SECURE THE BONE AND IMPLANTED THE COMPONENTS IN A NORMAL FASHION."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BOX CHISEL | INSTRUMENT | KDG | STRYKER ORTHOPAEDICS MAHWAH | NA | PYKJF |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |