MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-05-24 for BIPASS PLASTIC NITINOL DISP X1 N/A 902093 manufactured by Biomet Orthopedics.
[2654668]
It was reported that patient underwent rotator cuff repair procedure on (b)(6) 2012. During the procedure, the nitinol wire fractured while passing through tissue. The wire was retrieved from the surgical site, and the procedure was completed, but only after a delay of more than half an hour had occurred.
Patient Sequence No: 1, Text Type: D, B5
[9868189]
Review of device history records show that lot released with no recorded anomaly or deviation. Review of returned suture passer found that the tip of the top jaw on the device was worn. This reduces the length of the tip and allows the nitinol to not follow the tip. The nitinol would go in front of the tip of the inserter, and could fracture. This report is number 1 of 2 mdrs filed for the same event (reference 1825034-2012-00654 / 00655).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2012-00654 |
| MDR Report Key | 2586114 |
| Report Source | 07 |
| Date Received | 2012-05-24 |
| Date of Report | 2012-04-24 |
| Date of Event | 2012-04-23 |
| Date Mfgr Received | 2012-04-24 |
| Device Manufacturer Date | 2011-11-23 |
| Date Added to Maude | 2012-05-24 |
| 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 | MS. ANGELA DICKSON |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5743711021 |
| 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 | BIPASS PLASTIC NITINOL DISP X1 |
| Generic Name | PUSHER/SOCKET |
| Product Code | HXO |
| Date Received | 2012-05-24 |
| Returned To Mfg | 2012-05-11 |
| Model Number | N/A |
| Catalog Number | 902093 |
| Lot Number | 208360 |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | R |
| 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 | 1. Hospitalization; 2. Required No Informationntervention | 2012-05-24 |