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 2016-07-21 for ULTRA-DRIVE 3 N/A 423935 manufactured by Biomet Orthopedics.
[50102007]
The product identification necessary to review manufacturing history was not provided. Current information is insufficient to permit a conclusion as to the cause of the event. The following sections could not be completed with the limited information provided. Device requested, not yet received.
Patient Sequence No: 1, Text Type: N, H10
[50102008]
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
[65046902]
This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch, and corrected information. Device forwarded to supplier for evaluation. This report is for 1 of 2 devices that may have been involved in the event, as it is unknown which device was used (reference1825034-2016-02687 & 1825034-2017-00161). This report is number 2 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
[69338391]
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 who then evaluated the device. Based on the supplier evaluations, the complaint of a malfunctioning unit is confirmed, as there was no power on the returned device and several fuses were blown. The supplier relayed that it was found that the fuse holder was cracked, calibration seal broken, and that 14 screws from the cover were too long. Also, c95 was shorted which caused the 24v dc supply to be shorted to the ground. This caused the console to not power on. 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 was noted by the supplier that the console is over 9 years old and this complaint is likely age and wear related. The device was repaired and retested, with no further issues identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2016-02687 |
| MDR Report Key | 5812125 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-07-21 |
| Date of Report | 2016-06-22 |
| Date of Event | 2016-06-22 |
| Date Mfgr Received | 2017-02-13 |
| Device Manufacturer Date | 2007-01-08 |
| Date Added to Maude | 2016-07-21 |
| 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. MEGAN HAAS |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5743726700 |
| 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 3 |
| Generic Name | DEVICE, NERVE CONDUCTION VELOCITY MEASUREMENT |
| Product Code | JXE |
| Date Received | 2016-07-21 |
| Model Number | N/A |
| Catalog Number | 423935 |
| Lot Number | 25225 |
| ID Number | N/A |
| 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. Required No Informationntervention | 2016-07-21 |