MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-01 for N/A manufactured by Stryker Instruments.
[101299642]
Patient Sequence No: 1, Text Type: N, H10
[101299643]
Portable powered saw to be used during the case was faulty; the clutch was damaged, causing inadequate cutting of bone, necessitating replacement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7305763 |
| MDR Report Key | 7305763 |
| Date Received | 2018-03-01 |
| Date of Report | 2018-02-27 |
| Date of Event | 2018-02-06 |
| Report Date | 2018-02-27 |
| Date Reported to FDA | 2018-02-27 |
| Date Reported to Mfgr | 2018-02-27 |
| Date Added to Maude | 2018-03-01 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| 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 |
| Generic Name | PORTABLE POWERED SAGITTAL SAW |
| Product Code | GAF |
| Date Received | 2018-03-01 |
| Model Number | N/A |
| Catalog Number | N/A |
| Lot Number | N/A |
| Device Expiration Date | 2018-01-01 |
| Operator | PHYSICIAN |
| Device Availability | * |
| Device Age | 5 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER INSTRUMENTS |
| Manufacturer Address | 4100 EAST MILHAM AVE. KALAMAZOO MI 49001 US 49001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-01 |