MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MAXFIRE MARXMEN CURVED; FASTENER, FIXATION

Model Number N/A

Device Problem Migration (4003)

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

Event Date 07/27/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: 900321, maxfire marxmen curved, 925450.(b)(6).(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event.

Event Description

It was reported that during a meniscal repair procedure, the anchor pulled out from the meniscus when the surgeon pulled the suture to tie up.Another device was utilized to successfully complete the procedure.No patient consequences were reported as a result of the malfunction.No additional information is available.

Manufacturer Narrative

Upon reassessment of the reported event it was determined that the event will be reported on 0001825034-2018-08370.Hence the initial report submitted needs to be voided.

Event Description

No additional information is made available at this time.

• Brand Name: MAXFIRE MARXMEN CURVED
• Type of Device: FASTENER, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7819411
• MDR Text Key: 118322849
• Report Number: 0001825034-2018-08369
• Device Sequence Number: 1
• Product Code: JDR
• 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: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/29/2022
• Device Model Number: N/A
• Device Catalogue Number: 900321
• Device Lot Number: 925450
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/30/2018
• Initial Date FDA Received: 08/27/2018
• Supplement Dates Manufacturer Received: 01/25/2019
• Supplement Dates FDA Received: 01/28/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2017
• 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