MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MINI TRAY +10MM COCR +3 OFFSET; SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES

Model Number	N/A
Medical Device Problem Codes	Device Damaged Prior to Use (2284); Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the sterile packaging was worn and the implant had a smudge on it.Subsequently, the surgeon did not use the implant and another implant was opened.No harm to the patient was reported.
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.
Event or Problem Description
No additional event information to report at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual examination of the provided pictures identified the device pouch is scuffed and dimpled, and the device does have a scuffing or smudging in in the center and along the edge of the tray.However, as the pouch is open in the photo, it cannot be determined when the device smudge occurred.Additionally, as the products were not returned and all parts of the packaging cannot be seen in the photo, it cannot be determined if sterility was compromised.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.The root cause of the reported issue for pouch damage is attributed to transit damage.The root cause of the reported issue for the device smudge cannot be determined as the product was not returned and the packaging was opened in the provided photo.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: MINI TRAY +10MM COCR +3 OFFSET
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES
• 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: 14496306
• Report Number: 0001825034-2022-01252
• Device Sequence Number: 14954794
• Product Code: KWS
• UDI-Device Identifier: 00887868231360
• UDI-Public: (01)00887868231360(17)291231(10)64627085
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2022

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: 110031404
• Device Lot Number: 64627085
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2022
• Supplement Date Received by Manufacturer: 06/30/2022
• Initial Report FDA Received Date: 05/25/2022
• Supplement Report FDA Received Date: 07/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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
• Patient Sex: Unknown