MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-19 for STRYKER PERFORMANCE SERIES SAGITTAL BLADE 6221-127-090 manufactured by Stryker Sustainability Solutions, Inc.
[89710838]
Patient Sequence No: 1, Text Type: N, H10
[89710839]
Doctor was doing a total knee arthroplasty when he turned around and said that the blade that he was using was not sharp and that he felt that it was a refurbished blade. The doctor was given a new sharp blade.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6961180 |
| MDR Report Key | 6961180 |
| Date Received | 2017-10-19 |
| Date of Report | 2017-10-09 |
| Date of Event | 2017-10-06 |
| Report Date | 2017-10-09 |
| Date Reported to FDA | 2017-10-09 |
| Date Reported to Mfgr | 2017-10-09 |
| Date Added to Maude | 2017-10-19 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STRYKER PERFORMANCE SERIES SAGITTAL BLADE |
| Generic Name | BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL |
| Product Code | HSZ |
| Date Received | 2017-10-19 |
| Catalog Number | 6221-127-090 |
| Lot Number | 17083017 |
| ID Number | 6221-127-700 REV-C |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | STRYKER SUSTAINABILITY SOLUTIONS, INC |
| Manufacturer Address | 1810 W. DRAKE DR. TEMPE AZ 85283 US 85283 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-19 |