MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MINI COMP REV TRAY 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	12/12/2019
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 that the post on the trial broke when surgeon was trying to dislocate shoulder.No additional information is available at this time.
Event or Problem Description
Upon receipt of additional information it has been determined that this is not a reportable issue as the malfunction did not cause any serious injury in the past.The initial report was submitted in error and needs to be voided.
Additional Manufacturer Narrative
(b)(4).Upon receipt of additional information it has been determined that this is not a reportable issue as the malfunction did not cause any serious injury in the past.The initial report was submitted in error and needs to be voided.

• Brand Name: MINI COMP REV TRAY TRIAL
• Common Device Name: PROSTHESIS SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9546037
• Report Number: 0001825034-2020-00038
• Device Sequence Number: 14024185
• Product Code: KWS
• UDI-Device Identifier: 00887868231643
• UDI-Public: (01)00887868231643
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 05/18/2020

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: 110031431
• Device Lot Number: 64327855
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/15/2019
• Supplement Date Received by Manufacturer: 05/15/2020
• Initial Report FDA Received Date: 01/03/2020
• Supplement Report FDA Received Date: 05/18/2020
• 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