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 2015-08-12 for BIPASS DISPOSABLE NITINOL PUSHER SINGLE N/A 902092 manufactured by Biomet Orthopedics.
[22814097]
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. There are warnings in the package insert that state that this type of event can occur: "top jaw must remain fully closed to ensure proper suture passing. Failure to ensure jaw remains fully closed may result in device malfunction. " 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
[22814098]
It was reported that patient underwent an arthroscopic procedure on (b)(6) 2015. During the procedure, the nitinol pusher did not push the suture through the bypass suture passer. A 40 minute delay occurred in the procedure.
Patient Sequence No: 1, Text Type: D, B5
[26890838]
Examination of returned device found no evidence of product non-conformance.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2015-03581 |
| MDR Report Key | 4997574 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2015-08-12 |
| Date of Report | 2015-08-18 |
| Date of Event | 2015-07-13 |
| Date Mfgr Received | 2015-08-18 |
| Device Manufacturer Date | 2015-06-10 |
| Date Added to Maude | 2015-08-12 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. MEGAN HAAS |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5743726700 |
| 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 PUSHER SINGLE |
| Generic Name | PASSER, SOCKET |
| Product Code | HXO |
| Date Received | 2015-08-12 |
| Returned To Mfg | 2015-07-28 |
| Model Number | N/A |
| Catalog Number | 902092 |
| Lot Number | 367170 |
| 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. Required No Informationntervention | 2015-08-12 |