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 2017-01-16 for ULTRA-DRIVE III CONSOLE NI 423935 manufactured by Biomet Orthopedics.
[64886833]
Current information is sufficient to permit a conclusion as to the case of the event. This report is for 1 of 2 devices that may have been involved in the event, as it is unknown which device was used (reference 1825034-2016-02687 & 1825034-2017-00161). Device forwarded to supplier for evaluation. This report is number 1 of 6 mdrs filed for the same patient (reference 0001825034-2016-02687/1825034-2017-00161/0001822565 - 2016? 04474/3007963827 - 2016? 00079/0002648920 - 2016? 03314/0001822565 - 2016? 04482).
Patient Sequence No: 1, Text Type: N, H10
[64886834]
During a knee revision procedure, the handpieces of the cement removal system showed an error message. Flexible osteotomes were used to complete the procedure and there was a 45 minute delay.
Patient Sequence No: 1, Text Type: D, B5
[69339436]
This follow-up report is being filed to relay additional information which was unknown at the time of the initial medwatch. Concomitant products: catalog #: 423937, ultra-drive iii footswitch, lot # f1280; catalog #: 423936, ultra-drive iii handpiece, lot # 42257; catalog #: 423936, ultra-drive iii handpiece, lot # 42256; catalog #: 423937, ultra-drive iii footswitch, lot # f1202; catalog #: 423936, ultra-drive iii handpiece, lot # 42255; catalog #: 423936, ultra-drive iii handpiece, lot # 42254. Device was evaluated by supplier, and evaluation results forwarded to zimmer biomet. The console was received and forwarded to the supplier for evaluation. Based on the supplier evaluations, the complaint of the malfunctioning unit is confirmed. During the supplier's evaluation, it was noted that there was one loose foot, a locker loose inside the case, the j3 ribbon cable was worn through the insulation into the wire, does not run, the solder joint at r303 degraded from overheating, and that the v4 processor failure caused the hand piece ground fault error. Also, the processor v4 on the main power pc board failed internally so the outputs were no longer correct. This device is used for treatment. Review of the manufacture and repair records indicate the product was conforming when it left zimmer biomet control and the consoles have not underwent previous repairs. It is noted in the evaluation that the console is 6 years old and this complaint is likely age and wear related. The console was repaired and tested, with no further issues identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2017-00161 |
| MDR Report Key | 6254900 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-01-16 |
| Date of Report | 2017-01-12 |
| Date of Event | 2016-06-22 |
| Date Mfgr Received | 2017-02-13 |
| Device Manufacturer Date | 2010-08-30 |
| Date Added to Maude | 2017-01-16 |
| 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 | 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 | BIOMET ORTHOPEDICS |
| 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 | 2017-01-16 |
| Model Number | NI |
| Catalog Number | 423935 |
| Lot Number | 25312 |
| ID Number | NI |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET ORTHOPEDICS |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2017-01-16 |