MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-26 for STRYKER SHAVER BLADE manufactured by Stryker Corp..
[185482347]
During the procedure the primary surgeon noted and felt that the shaver is not working right and sounds different. He inspected and noted that the shaver had a crack and charge in it and continued with the procedure. We have informed the vendor of this issue. Per the vendor during manufacturing of any item, you will have a small percent that make it past qc. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093946 |
| MDR Report Key | 9888470 |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-03-11 |
| Date Added to Maude | 2020-03-27 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STRYKER SHAVER BLADE |
| Generic Name | ARTHROSCOPE |
| Product Code | HRX |
| Date Received | 2020-03-26 |
| Lot Number | 19287CE2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER CORP. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-26 |