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

Model Number	N/A
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/07/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem Description
No additional event information is available at the time of this report.

• Brand Name: EZ PASS 70 DEGREE LEFT
• Common Device Name: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9584600
• Report Number: 0001825034-2020-00230
• Device Sequence Number: 14037359
• Product Code: HWQ
• UDI-Device Identifier: 00880304563759
• UDI-Public: (01)00880304563759
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2020

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 01/07/2020
• Supplement Date Received by Manufacturer: 06/08/2020
• Initial Report FDA Received Date: 01/13/2020
• Supplement Report FDA Received Date: 06/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1