MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EZ PASS 30 DEGREE RIGHT; PASSER

Model Number N/A

Device Problems Failure to Advance (2524); Mechanical Jam (2983)

Patient Problem No Information (3190)

Event Date 05/09/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during a labral repair procedure, the wire was caught inside the handle and did not release, essentially rendering the passer useless.No patient consequences were reported as a result of the malfunction.No additional information was provided.

Manufacturer Narrative

The follow-up report is being submitted to relay additional information.The following sections have been updated.Product was visually examined.The nitinol kite has been cut with the kite portion having been removed and not returned.The portion that was returned was able to pass completely through the wheels.The complaint event cannot be verified.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause could not 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.

• Brand Name: EZ PASS 30 DEGREE RIGHT
• Type of Device: PASSER
• 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: 7580492
• MDR Text Key: 110463417
• Report Number: 0001825034-2018-03805
• Device Sequence Number: 1
• Product Code: HWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/07/2021
• Device Model Number: N/A
• Device Catalogue Number: 904055
• Device Lot Number: 499610
• Other Device ID Number: (01) 00880304563766
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2018
• 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