MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-08-19 for BOX CHISEL 6541-4-709 manufactured by Stryker Orthopaedics Mahwah.
[1384106]
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. "
Patient Sequence No: 1, Text Type: D, B5
[8673300]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2249697-2010-01116 |
| MDR Report Key | 1815404 |
| Report Source | 07 |
| Date Received | 2010-08-19 |
| Date of Report | 2010-07-27 |
| Date of Event | 2010-07-21 |
| Date Mfgr Received | 2010-07-27 |
| Device Manufacturer Date | 2005-03-08 |
| Date Added to Maude | 2010-08-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JADWIGA DEGRADO |
| Manufacturer Street | 325 CORPORATE DR. |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer Phone | 2018315000 |
| Manufacturer G1 | STRYKER ORTHOPAEDICS MAHWAH |
| Manufacturer Street | 325 CORPORATE DR. |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07430 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BOX CHISEL |
| Generic Name | INSTRUMENT |
| Product Code | KDG |
| Date Received | 2010-08-19 |
| Model Number | NA |
| Catalog Number | 6541-4-709 |
| Lot Number | PYKJF |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER ORTHOPAEDICS MAHWAH |
| Manufacturer Address | MAHWAH NJ 07430 US 07430 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-08-19 |