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).Additional concomitant medical products: 900321 maxfire marxmen curved 925480.(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, please see associated reports: 0001825034 -2018 -08369.

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.

Event Description

No additional information is made available at this time.

Manufacturer Narrative

It is unclear at this point of time which lot was defective.Ln 925480 (exp date:sep 25, 2022, sep 25, 2017) or ln 925450 (exp date: sep 29, 2022, ep 29, 2017).The complaint is confirmed based on the returned device.Visual inspection show that the suture and anchor disassembled from the body and the anchor is fractured from the suture.It is unknown how the suture was cut at both ends of the anchor.Dhr review show no deviations or anomalies.A definite root cause cannot be determined with the information provided.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.

• Brand Name: MAXFIRE MARXMEN CURVED
• Type of Device: FASTENER, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7819409
• MDR Text Key: 118326862
• Report Number: 0001825034-2018-08370
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• PMA/PMN Number: PK111564
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• 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: 09/25/2022
• Device Model Number: N/A
• Device Catalogue Number: 900321
• Device Lot Number: SEE NARRATIVE IN H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2018
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1