MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-19 for SAGGITAL SAW BLADE PRECISION THIN OFFSET 2296-003-511 manufactured by Stryker Corp.
[73123764]
Patient Sequence No: 1, Text Type: N, H10
[73123765]
Surgeon was sawing and surgical scrub tech noticed that the saw was "sounding" weird. Originally thought it was the battery and inspected saw and realized that the blade was broken. Removed blade and there was a piece missing. Team was using c-arm at the time and shots were taken; no evidence of piece in surgical site. Portable xray was taken at end of case and read negative for foreign body.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6503013 |
| MDR Report Key | 6503013 |
| Date Received | 2017-04-19 |
| Date of Report | 2017-04-17 |
| Date of Event | 2017-04-17 |
| Report Date | 2017-04-17 |
| Date Reported to FDA | 2017-04-17 |
| Date Reported to Mfgr | 2017-04-17 |
| Date Added to Maude | 2017-04-19 |
| 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 |
| 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 | SAGGITAL SAW BLADE PRECISION THIN OFFSET |
| Generic Name | SAW, BONE, AC-POWERED |
| Product Code | DZH |
| Date Received | 2017-04-19 |
| Model Number | 2296-003-511 |
| Catalog Number | 2296-003-511 |
| Lot Number | 17026017 |
| Operator | PHYSICIAN |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER CORP |
| Manufacturer Address | 4100 EAST MILHAM AVE. KALAMAZOO MI 49001 US 49001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-19 |