MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MAXFIRE MARXMEN STRAIGHT STRAIGHT; STAPLE, FIXATION

Model Number N/A

Device Problem Positioning Failure (1158)

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

Event Date 09/28/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant product(s): catalog number: 900320 lot number: 082290.Catalog number: 900320 lot number: 232850.Catalog number: 900321.Report source: foreign: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to hospital discarding it as biohazard.The investigation is in process.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: 0001825034-2017-09339, 0001825034-2017-09340.

Event Description

It was reported that during a meniscal repair surgery, the anchor of this device did not deploy.Two other products experienced the same malfunction during this surgery.The surgeon used a different type of device to complete the surgery.No patient harm or significant delay was reported.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Review of the complaint history determined that no further actions are required.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not 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 STRAIGHT STRAIGHT
• Type of Device: STAPLE, 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: 6970195
• MDR Text Key: 90764993
• Report Number: 0001825034-2017-09341
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Initial,Followup
• Report Date: 11/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/18/2019
• Device Model Number: N/A
• Device Catalogue Number: 900320
• Device Lot Number: 845670
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2014
• 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