MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2013-04-29 for BIPASS PLASTIC NITINOL DISP X1 N/A 902093 manufactured by Biomet Orthopedics.
[3351457]
It was reported patient underwent a rotator cuff repair on (b)(6) 2013. During the procedure, three bipass sutures were used without success. The surgeon completed the procedure with another set and a bipass clamp. As a result, there was an hour and a half delay to the procedure.
Patient Sequence No: 1, Text Type: D, B5
[10694172]
Event is being reported to fda on one medwatch as a delay occurred. 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. 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
[11024172]
Dimensional evaluation found component to be within appropriate design specification. Evaluation of the explanted device found evidence the two needles bent where they were designed to if too much pressure was applied. The third needle which had the button fractured appeared to have been mis-loaded. There are warnings in the package insert that state that this type of event can occur: under warnings, number 4 states, "do not apply excessive force to the pusher actuator. Repeat step 3a if necessary to avoid excessive force. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2013-01186 |
| MDR Report Key | 3082753 |
| Report Source | 01,07 |
| Date Received | 2013-04-29 |
| Date of Report | 2013-04-02 |
| Date of Event | 2013-03-29 |
| Date Mfgr Received | 2013-04-02 |
| Device Manufacturer Date | 2013-01-05 |
| Date Added to Maude | 2013-04-29 |
| 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 | 5743711021 |
| 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 PLASTIC NITINOL DISP X1 |
| Generic Name | PUSHER, SOCKET |
| Product Code | HXO |
| Date Received | 2013-04-29 |
| Returned To Mfg | 2013-06-24 |
| Model Number | N/A |
| Catalog Number | 902093 |
| Lot Number | 357040 |
| 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 | 1. Hospitalization; 2. Required No Informationntervention | 2013-04-29 |