MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 36 MINI COMP BRNG TRIAL; PROSTHESIS SHOULDER

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.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
It was reported during an initial shoulder surgery that the reverse shoulder 36 mm standard bearing trial broke.A piece broke off after trialing and taking out of patient with hemostat.
Additional Manufacturer Narrative
Upon reassessment of the reported information, it has been determined that this device did not cause or contribute to the reported event.The initial report was submitted in error.Hence it needs to be voided.
Event or Problem Description
Upon reassessment of the reported information, it has been determined that this device did not cause or contribute to the reported event.The initial report was submitted in error.Hence it needs to be voided.

• Brand Name: 36 MINI COMP BRNG TRIAL
• Common Device Name: PROSTHESIS SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9431938
• Report Number: 0001825034-2019-05485
• Device Sequence Number: 2237202
• Product Code: KWS
• UDI-Device Identifier: 00887868231735
• UDI-Public: 00887868231735
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K181611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2020

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 Model Number: N/A
• Device Catalogue Number: 110031441
• Device Lot Number: 64321517
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/22/2019
• Supplement Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 12/06/2019
• Supplement Report FDA Received Date: 01/29/2020
• 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