MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-20 for UNIVERSAL OSCILLATING SAW ATTACHMENT 89-8509-450-60 manufactured by Zimmer Surgical Sa.
[24659389]
At the date of the present report, the product was not returned to the manufacturer. The investigation is then not completed. A medwatch follow-up will be submitted when the investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
[24659390]
It has been reported that three pins of the oscillating saw attachment were broken. No patient was involved in this event since it occurred prior to surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8031000-2015-00103 |
| MDR Report Key | 5017234 |
| Date Received | 2015-08-20 |
| Date of Report | 2015-07-29 |
| Date of Event | 2015-07-28 |
| Date Mfgr Received | 2015-07-29 |
| Date Added to Maude | 2015-08-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | CECILE GUIOT |
| Manufacturer Street | CHEMIN PRE FLEURI 3 |
| Manufacturer City | PLAN-LES-OUATES, GENEVA CH-1228 |
| Manufacturer Country | SZ |
| Manufacturer Postal | CH-1228 |
| Manufacturer Phone | 7062106 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | UNIVERSAL OSCILLATING SAW ATTACHMENT |
| Generic Name | UNIVERSAL OSCILLATING SAW ATTACHMENT |
| Product Code | DWI |
| Date Received | 2015-08-20 |
| Model Number | NA |
| Catalog Number | 89-8509-450-60 |
| Lot Number | 5000951 |
| ID Number | NA |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER SURGICAL SA |
| Manufacturer Address | CHEMIN PRE FLEURI 3 PLAN-LES-OUATES, GENEVA CH-1228 SZ CH-1228 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-20 |