MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-08-24 for ULTRA-DRIVE III HANDPIECE N/A 423936 manufactured by Zimmer Biomet, Inc..
[118104799]
(b)(4). Foreign country: (b)(6). Product has been received by zimmer biomet and 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 - 2018 - 08518 ,0001825034 - 2018 - 08520.
Patient Sequence No: 1, Text Type: N, H10
[118104800]
It was reported that, during surgery, the device made a strange noise and error messages were displayed on the front panel of the device and ultimately the device stopped working, causing a delay to the procedure over thirty (30) minutes. Surgery was completed with manual instrumentation successfully. No additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2018-08521 |
| MDR Report Key | 7812452 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-08-24 |
| Date of Report | 2018-08-23 |
| Date of Event | 2018-07-26 |
| Date Mfgr Received | 2018-07-27 |
| Device Manufacturer Date | 2011-10-11 |
| Date Added to Maude | 2018-08-24 |
| 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 HANDPIECE |
| Generic Name | DEVICE, NERVE CONDUCTION VELOCITY MEASUREMENT |
| Product Code | JXE |
| Date Received | 2018-08-24 |
| Returned To Mfg | 2018-08-01 |
| Model Number | N/A |
| Catalog Number | 423936 |
| Lot Number | 42480 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 423935 | 1. Hospitalization | 2018-08-24 |