MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-10-12 for BIPASS DISP NITINOL SINGLE N/A 902092 manufactured by Biomet Orthopedics.
[10269811]
Examination of returned device found device appears to have been used many times and the shear tear on the pusher indicates an inadvertent error by the operator. There are warnings in the surgical technique that state that this type of event can occur: "front jaw & trigger must be completely closed and locked for proper suture passing. Failure to ensure jaw is properly closed may result in device malfunction. "
Patient Sequence No: 1, Text Type: N, H10
[20234136]
It was reported patient underwent rotator cuff procedure on (b)(6) 2012. During the procedure, the bypass suture pusher fractured and had to be retrieved from the surgical site. The procedure was finished using a competitors product.
Patient Sequence No: 1, Text Type: D, B5
[20538284]
The user facility is outside of the united states. No medwatch report was received. 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. Evaluation in process but not yet complete. Upon completion of evaluation, a follow up report will be sent to the fda. This report is number 1 of 1 mdrs filed for this event (reference 1825034-2012-01947).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2012-01947 |
| MDR Report Key | 2786382 |
| Report Source | 07 |
| Date Received | 2012-10-12 |
| Date of Report | 2012-09-21 |
| Date of Event | 2012-09-19 |
| Date Mfgr Received | 2012-09-21 |
| Device Manufacturer Date | 2012-03-22 |
| Date Added to Maude | 2012-10-12 |
| 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. ANGIE DICKSON |
| Manufacturer Street | 56 EAST BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5742676639 |
| Manufacturer G1 | BIOMET ORTHOPEDICS |
| Manufacturer Street | 56 EAST 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 DISP NITINOL SINGLE |
| Generic Name | PUSHER, SOCKET |
| Product Code | HXO |
| Date Received | 2012-10-12 |
| Returned To Mfg | 2012-10-10 |
| Model Number | N/A |
| Catalog Number | 902092 |
| Lot Number | 267410 |
| ID Number | N/A |
| Device Expiration Date | 2017-03-31 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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 | 2012-10-12 |