MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MAXFIRE MARXMEN STRAIGHT STRAIGHT; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number 900320

Device Problem Failure to Discharge (1169)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/15/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.

Event Description

It was reported the device misfired and failed to deploy the anchor.The surgery was completed without delay with another device.No further information available.

Event Description

No further information available at the time of this reporting.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Examination of the returned device does not confirm the reporting; the device performs as expected and intended.Review of device history records did not identify any related manufacturing deviations or anomalies that would have contributed to the reported event.Root cause is undetermined.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: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8331882
• MDR Text Key: 135909185
• Report Number: 0001825034-2019-00600
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• PMA/PMN Number: K111564
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 05/16/2019

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: 03/28/2023
• Device Catalogue Number: 900320
• Device Lot Number: 580710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/11/2019
• Initial Date FDA Received: 02/12/2019
• Supplement Dates Manufacturer Received: 05/13/2019
• Supplement Dates FDA Received: 05/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1