MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EZ PASS 70 DEGREE LEFT; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Failure to Advance (2524)

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

Event Date 01/07/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Event occurred in (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up/final report will be submitted.Not returned to manufacturer.

Event Description

It was reported that during the surgery, the wire couldn't push out from this device although the surgeon rolled the roller of the device.No further information is available at the time of this reporting.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d10, g4, g7, h1, h2, h3, h6, h10 visual examination of the returned product identified no damages to the handle or kite.The device functioned as intended.Device history record (dhr) was reviewed and no discrepancies were found.Review of the device determined that no failure was found as the product functions as intended.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.

Event Description

No additional event information is available at the time of this report.

• Brand Name: EZ PASS 70 DEGREE LEFT
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9584600
• MDR Text Key: 195162981
• Report Number: 0001825034-2020-00230
• Device Sequence Number: 1
• Product Code: HWQ
• UDI-Device Identifier: 00880304563759
• UDI-Public: (01)00880304563759
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2021
• Device Model Number: N/A
• Device Catalogue Number: 904054
• Device Lot Number: 738900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1