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 2018-05-30 for ULTRA-DRIVE III CONSOLE N/A 423935 manufactured by Zimmer Biomet, Inc..
[109512536]
(b)(4). (b)(6). Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[109512537]
It was reported that during surgery, the instrument front panel lights were lit up and the console was frozen, making the device unusable. No delay or patient harm occurred as a result of the malfunction. No other additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
[125689220]
The follow up report is submitted to relay additional information received. The complaint is confirmed based on the returned complaint sample. Review of the device history record identified no deviations or anomalies would contribute to reported event. The root cause of this event can be attributed to age and usage related since the device was on the field for twelve 12 years. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.
Patient Sequence No: 1, Text Type: N, H10
[125689221]
It was reported that during surgery, the instrument front panel lights were lit up and the console was frozen, making the device unusable. No delay or patient harm occurred as a result of the malfunction. No other additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2018-03674 |
| MDR Report Key | 7552771 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2018-05-30 |
| Date of Report | 2018-10-26 |
| Date of Event | 2018-05-01 |
| Date Mfgr Received | 2018-10-10 |
| Date Added to Maude | 2018-05-30 |
| 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 CONSOLE |
| Generic Name | DEVICE, NERVE CONDUCTION VELOCITY MEASUREMENT |
| Product Code | JXE |
| Date Received | 2018-05-30 |
| Returned To Mfg | 2018-05-30 |
| Model Number | N/A |
| Catalog Number | 423935 |
| Lot Number | 25203 |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | R |
| 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 | 2018-05-30 |