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

Model Number N/A

Device Problem Disassembly (1168)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Complaint sample was evaluated and the reported event was confirmed.Product was visually examined and with both returned marxmen devices the pusher needle was disengaged from the sled without sutures confirming the condition of the reported complaint.Close inspection of pusher needles show discoloration on end that would be inserted into the assembly of the marxmen.Discoloration could be attributed to glue that is placed on pusher needles during assembly.The needle pushers were able to be inserted back into the main assembly and move correctly when the trigger was pressed and did not disengage.As device is single use and implantable sutures were not present a full functional test was not possible.Device history record (dhr) was reviewed and no discrepancies were found.Review of the complaint history determined that no further action(s) is/are required.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.Multiple mdr reports were filed for this event, please see associated reports: 1825034-2017-03591.

Event Description

It was reported that operation for meniscal repair was performed with marxmen on an unknown date.When surgeon pulled trigger of marxmen, the pusher dropped before the anchor came out.This problem recurred with another marxmen.Surgery was completed with a third marxmen.No further information has been provided.

• Brand Name: MAXFIRE MARXMEN CURVED
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6633142
• MDR Text Key: 77311475
• Report Number: 0001825034-2017-03594
• 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: 06/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/30/2017
• Device Model Number: N/A
• Device Catalogue Number: 900321
• Device Lot Number: 425690
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2012
• 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