MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DVR VOLAR RIM R ST; APPLIANCE, FIXATION

Model Number	131814051
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that upon inspection in the warehouse, it was found that there was scratch on the sterile package.No adverse event has been reported as a result of the malfunction.
Additional Manufacturer Narrative
(b)(4).Report source: foreign: (b)(6).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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned product identified damage to the sterile packaging (inner pouch).Sterility has not been compromised.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as it cannot be determined if the scratch occurred during manufacturing or transit.The device evaluation found the product to be conforming and sterility not compromised.Further, the event did not contribute to a serious injury; therefore, this would not be considered a reportable event.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: DVR VOLAR RIM R ST
• Common Device Name: APPLIANCE, FIXATION
• 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: 13976577
• Report Number: 0001825034-2022-00777
• Device Sequence Number: 4776917
• Product Code: LXT
• UDI-Device Identifier: 00880304814769
• UDI-Public: (01)00880304814769(17)320201(10)351430
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K132704
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2022

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: 131814051
• Device Catalogue Number: 131814051
• Device Lot Number: 351430
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2022
• Supplement Date Received by Manufacturer: 05/20/2022
• Initial Report FDA Received Date: 04/01/2022
• Supplement Report FDA Received Date: 06/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown