MAUDE Adverse Event Report: BIOMET SPORTS MEDICINE BIPASS DISPOSABLE NITINOL PUSH ER SINGLE; PUSHER, SOCKET

Model Number N/A

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/25/2016

Event Type  malfunction  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show the 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 instructions for use, it states, "carefully read the following instructions prior to surgical use.Top jaw must remain fully closed to ensure proper suture passing.Failure to ensure jaw remains fully closed may result in device malfunction.".

Event Description

The surgeon was unable to utilize the nitinol wire to pass the suture through the rotator cuff.Subsequently, this same issue occurred with a second nitinol wire.A competitor instrument was used to complete the procedure with minimal delay.

• Brand Name: BIPASS DISPOSABLE NITINOL PUSH ER SINGLE
• Type of Device: PUSHER, SOCKET
• Manufacturer (Section D): BIOMET SPORTS MEDICINE; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6121923
• MDR Text Key: 60755356
• Report Number: 0001825034-2016-04819
• Device Sequence Number: 1
• Product Code: HXO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 902092
• Device Lot Number: 288120
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2016
• 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