MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2015-05-12 for ULTRA-DRIVE III HANDPIECE N/A 423936 manufactured by Biomet Orthopedics.
[5788451]
It was reported that patient underwent a competitor total knee revision on (b)(6) 2015. During the procedure, the cord sparked causing a small hole to be burnt in the surgical drape. There was no contact with the patient and a patch was used on the drape to complete the procedure.
Patient Sequence No: 1, Text Type: D, B5
[13382343]
Device availability - the device is reported to be available for evaluation; however, it has not been received by biomet orthopedics to date. In the event that the device is received and evaluated, a follow up report will be sent to the fda to provide results.
Patient Sequence No: 1, Text Type: N, H10
[13484096]
Examination of returned device found no evidence of product non-conformance. Evaluation of returned device found evidence that instrument sparked due to excessive cable bending and age of the product.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2015-01956 |
| MDR Report Key | 4764502 |
| Report Source | 07 |
| Date Received | 2015-05-12 |
| Date of Report | 2015-06-12 |
| Date of Event | 2015-04-10 |
| Date Mfgr Received | 2015-06-12 |
| Device Manufacturer Date | 2007-01-30 |
| Date Added to Maude | 2015-06-09 |
| 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 | 0 |
| Event Location | 0 |
| 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 III HANDPIECE |
| Generic Name | DEVICE |
| Product Code | JXE |
| Date Received | 2015-05-12 |
| Returned To Mfg | 2015-04-20 |
| Model Number | N/A |
| Catalog Number | 423936 |
| Lot Number | 42248 |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2015-05-12 |