MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-06-23 for DISCOVERY BEARING ROTATION TOOL N/A 414952 manufactured by Biomet Orthopedics.
[9208874]
(b)(4). This report filed (b)(4), 2011. -(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[21641804]
It was reported that patient underwent total elbow arthroplasty on (b)(6) 2011 and that a subsequent revision to exchange the poly ulna bearing was performed on (b)(6) 2011 due to infection. During the revision, the surgeon debrided the wound and attempted to exchange the ulna bearing; however, the bearing rotation tool was noted to be fractured and resulted in damage to the implant. The procedure could not be completed and another revision procedure was performed on (b)(6) 2011, after a new bearing rotation tool was received.
Patient Sequence No: 1, Text Type: D, B5
[21872924]
Current information is insufficient to permit a conclusion as to the cause of the event. Review of device history records show that lot released with no recorded anomaly or deviation. There are warnings in the associated package insert that state that this type of event can occur: "intraoperative fracture or breaking of instruments has been reported. Surgical instruments are subject to wear with normal usage. Instruments that have experienced extensive use or excessive force are susceptible to fracture. Surgical instruments should only be used for their intended purpose. Biomet recommends that all instruments be regularly inspected for wear and disfigurement. " evaluation in process but not yet complete. Upon completion of evaluation, a follow up report will be sent to the fda. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1825034-2011-00526 |
| MDR Report Key | 2138526 |
| Report Source | 06 |
| Date Received | 2011-06-23 |
| Date of Report | 2011-05-31 |
| Date of Event | 2011-05-22 |
| Date Mfgr Received | 2011-05-31 |
| Device Manufacturer Date | 2010-09-15 |
| Date Added to Maude | 2011-06-24 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. CRAIG BUCHMAN |
| Manufacturer Street | 56 EAST BELL DRIVE P.O. BOX 587 |
| Manufacturer City | WARSAW IN 465810587 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810587 |
| Manufacturer Phone | 5743711132 |
| Manufacturer G1 | BIOMET ORTHOPEDICS |
| Manufacturer Street | 56 EAST BELL DRIVE P.O. BOX 587 |
| Manufacturer City | WARSAW IN 46581058 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46581 0587 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DISCOVERY BEARING ROTATION TOOL |
| Generic Name | DEVICE, PROSTHESIS ALIGNMENT |
| Product Code | IQO |
| Date Received | 2011-06-23 |
| Returned To Mfg | 2011-05-31 |
| Model Number | N/A |
| Catalog Number | 414952 |
| Lot Number | 293910 |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET ORTHOPEDICS |
| Manufacturer Address | 56 EAST BELL DRIVE P.O. BOX 587 WARSAW IN 46581058 US 46581 0587 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2011-06-23 |