MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2014-02-11 for BIPASS NITINOL 10 PACK PLASTIC N/A 902091 manufactured by Biomet Orthopedics.
[4134667]
It was reported patient underwent a double row repair procedure on (b)(6) 2014. During the procedure, the tip of the bipass needle fractured while bringing the thread through the rotator sleeve. The fractured tip remains in the patient. A 45 minute delay occurred during the procedure.
Patient Sequence No: 1, Text Type: D, B5
[11643228]
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. 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
[11766150]
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: under warnings, number 2 states, " the bipass suture passer and pusher were designed for use with maxbraidsuture. Use of bipass instruments with suture from other manufacturers may compromise the integrity of the instrument and/or suture. " examination of returned device found no evidence of product non-conformance. During the evaluation, it was noted the nitinol bypass suture was used with sutures from another manufacturer and thereby the integrity of the instrument was compromised.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2014-00765 |
| MDR Report Key | 3621867 |
| Report Source | 01,07 |
| Date Received | 2014-02-11 |
| Date of Report | 2014-03-17 |
| Date of Event | 2014-01-15 |
| Date Mfgr Received | 2014-03-17 |
| Device Manufacturer Date | 2013-05-01 |
| Date Added to Maude | 2014-02-11 |
| 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. AMANDA ZAJICEK |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5743726782 |
| 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 NITINOL 10 PACK PLASTIC |
| Generic Name | PUSHER, SOCKET |
| Product Code | HXO |
| Date Received | 2014-02-11 |
| Returned To Mfg | 2014-02-19 |
| Model Number | N/A |
| Catalog Number | 902091 |
| Lot Number | 369960 |
| 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 | 2014-02-11 |