MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-11-22 for BIPASS DISPOSABLE NITINOL PUSH ER SINGLE N/A 902092 manufactured by Biomet Sports Medicine.
[60755356]
Current information is insufficient to permit a conclusion as to the cause of the event. Review of device history records show the lot released with no recorded anomaly or deviation. There are warnings in the package insert that state that this type of event can occur: under instructions for use, it states, "carefully read the following instructions prior to surgical use. Top jaw must remain fully closed to ensure proper suture passing. Failure to ensure jaw remains fully closed may result in device malfunction. "
Patient Sequence No: 1, Text Type: N, H10
[60755357]
The surgeon was unable to utilize the nitinol wire to pass the suture through the rotator cuff. Subsequently, this same issue occurred with a second nitinol wire. A competitor instrument was used to complete the procedure with minimal delay.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2016-04819 |
| MDR Report Key | 6121923 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-11-22 |
| Date of Report | 2016-11-22 |
| Date of Event | 2016-10-25 |
| Date Mfgr Received | 2016-10-25 |
| Device Manufacturer Date | 2016-03-22 |
| Date Added to Maude | 2016-11-22 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CHRISTINA ARNT |
| Manufacturer Street | 56 E. BELL DR. |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| 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 DISPOSABLE NITINOL PUSH ER SINGLE |
| Generic Name | PUSHER, SOCKET |
| Product Code | HXO |
| Date Received | 2016-11-22 |
| Model Number | N/A |
| Catalog Number | 902092 |
| Lot Number | 288120 |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET SPORTS MEDICINE |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-22 |