MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2013-07-18 for UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE 89-8507-400-00 manufactured by Zimmer Surgical S.a..
[3665427]
It was reported that the universal modular electric/battery double trigger handpiece stuck. The device got jammed after sawing with the oscillating saw. The surgery was completed with another device. No add'l clinical info was rec'd prior to this report.
Patient Sequence No: 1, Text Type: D, B5
[10998016]
The device was not returned to the mfr at the time of this report. A follow up medwatch will be submitted once the device has been returned and the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8031000-2013-00128 |
| MDR Report Key | 3241101 |
| Report Source | 01,05,07 |
| Date Received | 2013-07-18 |
| Date of Report | 2013-06-20 |
| Date of Event | 2013-06-20 |
| Date Mfgr Received | 2013-06-20 |
| Date Added to Maude | 2013-10-16 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | CINDY DICKEY |
| Manufacturer Street | CHEMIN PRE FLEURI PLAN LES OUATES |
| Manufacturer City | GENEVA CH-1228 |
| Manufacturer Country | SZ |
| Manufacturer Postal | CH-1228 |
| Manufacturer Phone | 3303438801 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE |
| Generic Name | UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE |
| Product Code | DWH |
| Date Received | 2013-07-18 |
| Model Number | NA |
| Catalog Number | 89-8507-400-00 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER SURGICAL S.A. |
| Manufacturer Address | CHEMIN PRE FLEURI 3 PLAN LES OUATES GENEVA SZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-07-18 |