Model Number N/A |
Device Problems
Break (1069); Detachment Of Device Component (1104)
|
Patient Problem
Device Embedded In Tissue or Plaque (3165)
|
Event Date 01/15/2014 |
Event Type
Injury
|
Event Description
|
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.
|
|
Manufacturer Narrative
|
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.
|
|
Manufacturer Narrative
|
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.
|
|
Search Alerts/Recalls
|