MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2013-02-18 for BIPASS PLASTIC NITINOL DISPOSABLE X1 N/A 902093 manufactured by Biomet Sports Medicine.
[3139544]
It was reported that patient underwent a rotator cuff procedure on (b)(6) 2013. During the procedure, the tip of the bipass disposable pusher fractured. The fractured piece had to be retrieved from the patient. A new bipass disposable pusher was used to complete the procedure.
Patient Sequence No: 1, Text Type: D, B5
[10569319]
Evaluation in process but not yet complete. Upon completion of evaluation, a follow up report will be sent to the fda.
Patient Sequence No: 1, Text Type: N, H10
[10631555]
Evaluation of returned device found evidence that instrument fractured due to excessive force. 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. 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 | 0001825034-2013-00285 |
| MDR Report Key | 2966410 |
| Report Source | 01,07 |
| Date Received | 2013-02-18 |
| Date of Report | 2013-01-24 |
| Date of Event | 2013-01-24 |
| Date Mfgr Received | 2013-01-24 |
| Device Manufacturer Date | 2012-08-14 |
| Date Added to Maude | 2013-02-19 |
| 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 DISPOSABLE X1 |
| Generic Name | PUSHER, SOCKET |
| Product Code | HXO |
| Date Received | 2013-02-18 |
| Returned To Mfg | 2013-02-11 |
| Model Number | N/A |
| Catalog Number | 902093 |
| Lot Number | 883930 |
| 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 SPORTS MEDICINE |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2013-02-18 |