MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2017-11-01 for ULTRA-DRIVE III FOOTSWITCH N/A 423937 manufactured by Zimmer Biomet, Inc..
[90736904]
(b)(4). Concomitant medical products: 423935, ultra-drive iii console, 25135 report source, foreign? Events occurred in (b)(6). Customer has been indicated that the product will not be returned to zimmer biomet for investigation. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-09829 & 0001825034-2017-09825.
Patient Sequence No: 1, Text Type: N, H10
[90736905]
It was reported that during a total elbow revision the ultra drive was not working. The r pedal would not activate, and the pedal was changed. There was no difference. Once the console was changed, the ultra drive functioned properly. The procedure was delayed for 45 minutes. Attempts have been made and additional information on the reported event is unavailable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2017-09829 |
| MDR Report Key | 6992664 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2017-11-01 |
| Date of Report | 2018-11-27 |
| Date of Event | 2017-10-02 |
| Date Mfgr Received | 2018-11-26 |
| Date Added to Maude | 2017-11-01 |
| 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 | MS. CHRISTINA ARNT |
| Manufacturer Street | 56 E. BELL DR. |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| Manufacturer G1 | ZIMMER BIOMET, INC. |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRA-DRIVE III FOOTSWITCH |
| Generic Name | DEVICE, NERVE CONDUCTION VELOCITY MEASUREMENT |
| Product Code | JXE |
| Date Received | 2017-11-01 |
| Model Number | N/A |
| Catalog Number | 423937 |
| Lot Number | F1188P2 |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER BIOMET, INC. |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-11-01 |