MAUDE Adverse Event Report: BIOMET SPORTS MEDICINE MAXFIRE MARXMEN CURVED; FIXATION, STAPLE

Model Number N/A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/16/2015

Event Type  Injury  

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.This report is number 3 of 3 mdr's filed for the same event (reference 1825034-2015-03810, 03811 and 03812).

Event Description

It was reported that patient underwent lateral meniscus repair procedure on (b)(6) 2015.During the procedure three maxfire marxmen were unsuccessfully attempted for use.The anchors were removed from the patient and two additional marxmen were used to complete the procedure with no further complications.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be sent to the fda.This report is number 1 of 3 mdrs filed for the same event (reference 1825034-2015-03810-1 / 03811-1 / 03812-1).

Manufacturer Narrative

Examination of returned device found no evidence of product non-conformance.Evaluation of the device found it was bent and twisted.This damage to the device would deem them as not able to function.

Manufacturer Narrative

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

Event Description

It was reported that patient underwent lateral meniscus repair procedure on (b)(6) 2015.During the procedure three maxfire marxmen were unsuccessfully attempted for use.The anchors were removed from the patient and two additional marxmen were used to complete the procedure with no further complications.Additional information received reports that during the procedure, the anchors pulled out while the stitches were being tightened.

• Brand Name: MAXFIRE MARXMEN CURVED
• Type of Device: FIXATION, STAPLE
• 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: 5045808
• MDR Text Key: 24705891
• Report Number: 0001825034-2015-03812
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: PK061776
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Followup,Followup
• Report Date: 11/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 04/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 900321
• Device Lot Number: 520020
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/26/2015
• Was Device Evaluated by Manufacturer?: No
• 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