MAUDE Adverse Event Report: BIOMET SPORTS MEDICINE MAXFIRE REPAIR DEVICE WITH ZIPLOOP; FASTENER, FIXATION

Model Number N/A

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/05/2016

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.Method: manufacturing review.Product was received out of the packaging and disassembled, therefore the complaint cannot be substantiated.Review of manufacture records found that this product was made to print without any deviations or anomalies and left biomet control conforming.Given this, the most likely cause of the device being received disassembled would be transit conditions, however, a definitive root cause cannot be determined and the complaint cannot be verified.

Event Description

During an arthroscopic rotator cuff repair, the packaging was opened and it was discovered that the anchor was not on the inserter tip.Another was available and used to complete the procedure.

• Brand Name: MAXFIRE REPAIR DEVICE WITH ZIPLOOP
• Type of Device: FASTENER, FIXATION
• 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: 5986463
• MDR Text Key: 55890476
• Report Number: 0001825034-2016-03866
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK111564
• 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: 04/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 900339
• Device Lot Number: 736400
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2015
• 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