MAUDE Adverse Event Report: BIOMET ORTHOPEDICS BIPASS NITINOL 10 PACK PLASTIC; PUSHER, SOCKET

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.

• Brand Name: BIPASS NITINOL 10 PACK PLASTIC
• Type of Device: PUSHER, SOCKET
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: amanda zajicek ; 56 e. bell drive; warsaw, IN 46582 ; 5743726782
• MDR Report Key: 3621867
• MDR Text Key: 4134667
• Report Number: 0001825034-2014-00765
• Device Sequence Number: 1
• Product Code: HXO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 04/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 902091
• Device Lot Number: 369960
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention