MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2017-10-25 for ULTRA-DRIVE III CONSOLE N/A 423935 manufactured by Zimmer Biomet, Inc..
[90796663]
Complaint sample was evaluated and the reported event was confirmed. Device history record was reviewed and no discrepancies were found. Review of the complaint history determined that no further action is required as no trends were identified. Problem was intermittent and could not be isolated. This time, the problem was isolated to a loose ground connection. Age and handling are a possible cause of the loose connection. Acetabular gouge coming out of one side, would not allow power amp to function. Also found 2 broken resistors in the phase feedback caused device not to function. Device repaired and returned to customer by supplier. Replaced broken resistors to restore phase feedback function. Replaced acetabular component to restore proper function of the hand piece. There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation: under section 6. Troubleshooting: if the likely solutions fail to correct the problem, contact ultra-drive 3 customer service. 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. This report is being submitted late as it has been identified in remediation.
Patient Sequence No: 1, Text Type: N, H10
[90796664]
It was reported that there was an intermittent problem with the ultra drive iii console on (b)(6) 2016 during a revision of a competitor reverse shoulder. The root cause was attributed to a loose ground wire connection. The humeral stem was removed with chisels and humeral extraction instrument and a zimmer biomet humeral implant was cemented.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2017-09685 |
| MDR Report Key | 6977606 |
| Report Source | OTHER |
| Date Received | 2017-10-25 |
| Date of Report | 2017-10-25 |
| Date of Event | 2016-01-22 |
| Date Mfgr Received | 2016-02-25 |
| Device Manufacturer Date | 2012-08-23 |
| Date Added to Maude | 2017-10-25 |
| 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 | 2017-10-25 |
| Returned To Mfg | 2016-02-26 |
| Model Number | N/A |
| Catalog Number | 423935 |
| Lot Number | 25372 |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-10-25 |