MAUDE Adverse Event Report: BIOMET SPORTS MEDICINE BIPASS DISPOSABLE NITINOL PUSH ER SINGLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number N/A

Device Problem Component or Accessory Incompatibility (2897)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/26/2016

Event Type  malfunction  

Manufacturer Narrative

The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.The following sections could not be completed with the limited information provided.Date of event ¿ ni.Initial reporter ¿ surgeon - ni.Manufacture date ¿ ni.This report is number 2 of 2 mdrs filed for the same patient (reference 1825034-2016-03803 / 03804).

Event Description

It was reported that there was significant resistance/friction of the nitinol needle passing through the suture punch.There was no patient injury or delay in procedure.A competitor product was used to complete this procedure.

Manufacturer Narrative

This follow-up report is being filed to relay this report is a duplicate of 1825034-2016-02271.

• Brand Name: BIPASS DISPOSABLE NITINOL PUSH ER SINGLE
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 5978065
• MDR Text Key: 55938010
• Report Number: 0001825034-2016-03804
• Device Sequence Number: 1
• Product Code: HXO
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 902092
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1