MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VNGD PS TIB BRG 12X63/67MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Report source: (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.
Event or Problem Description
It was reported that during a knee procedure, when the nurse opened the packaging for the tibial insert, it was noted that the inner sterile blister was not fully adhered.There was a 30 minute delay.No adverse events have been reported as a result of the malfunction.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was not confirmed.Visual examination of the returned product found the device in vacuum sealed sterile pouch with no visible damage.The flange of the sterile blister exhibits complete adhesive transfer from tyvek with no voids.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the issue could not be confirmed.A summary of the investigation has been sent to the complainant.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: VNGD PS TIB BRG 12X63/67MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11932996
• Report Number: 0001825034-2021-01698
• Device Sequence Number: 14223209
• Product Code: JWH
• UDI-Device Identifier: 00880304271869
• UDI-Public: (01)00880304271869(17)221001(10)344650
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K113550
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2021

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: 10/01/2022
• Device Model Number: N/A
• Device Catalogue Number: 183622
• Device Lot Number: 344650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/10/2021
• Supplement Date Received by Manufacturer: 07/12/2021
• Initial Report FDA Received Date: 06/03/2021
• Supplement Report FDA Received Date: 07/13/2021
• 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
• Patient Weight: 53