MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-08 for PRECISION FALCON 6725-127-105 manufactured by Stryker Corp..
[82031014]
Patient Sequence No: 1, Text Type: N, H10
[82031015]
Surgeon was using the stryker oscillating tip saw cartridge during a total hip procedure. The tip broke off but was retrieved by the surgeon - it was not retained in the patient
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6773372 |
| MDR Report Key | 6773372 |
| Date Received | 2017-08-08 |
| Date of Report | 2017-07-18 |
| Date of Event | 2017-07-10 |
| Report Date | 2017-07-18 |
| Date Reported to FDA | 2017-07-18 |
| Date Reported to Mfgr | 2017-07-18 |
| Date Added to Maude | 2017-08-08 |
| 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 | PRECISION FALCON |
| Generic Name | BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL |
| Product Code | HSZ |
| Date Received | 2017-08-08 |
| Model Number | 6725-127-105 |
| Lot Number | 17062017 |
| ID Number | 1380148 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | STRYKER CORP. |
| Manufacturer Address | 5900 OPTICAL CT SAN JOSE CA 95138 US 95138 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-08 |