MAUDE Adverse Event Report: BIOMET ORTHOPEDICS MAXFIRE MARXMEN STRAIGHT; FASTENER, FIXATION

Model Number N/A

Device Problem Failure to Disconnect (2541)

Patient Problem No Information (3190)

Event Date 12/01/2014

Event Type  Injury  

Event Description

It was reported patient underwent a meniscal repair procedure on (b)(6) 2014.During the procedure, the second anchor was blocked by the guide and could not disengage.Another maxfire marxmen system was utilized to complete 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.

Manufacturer Narrative

This follow-up report is being filed to relay information which was unknown at the time of the initial medwatch.

Event Description

It was reported patient underwent a meniscal repair procedure on (b)(6) 2014 utilizing a meniscal repair device loaded with two suture anchors.During the procedure, after the first anchor had deployed, the second anchor was blocked by the guide and could not disengage.The first anchor was removed and a second hole was drilled to complete the procedure with another meniscal repair device.

• Brand Name: MAXFIRE MARXMEN STRAIGHT
• Type of Device: FASTENER, FIXATION
• 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: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 4367010
• MDR Text Key: 5290515
• Report Number: 0001825034-2014-09289
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK111564
• 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: 01/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 02/28/2017
• Device Model Number: N/A
• Device Catalogue Number: 900320
• Device Lot Number: 978880
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2012
• 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): Required Intervention