MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD FEM PEGS SET 2; PROSTHESIS, KNEE

Model Number	183099
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign: japan.Customer has indicated that the packaging 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 an initial total knee arthroplasty, the surgeon found that the inner sterile packaging of the distal femoral peg component was torn and disintegrated.The surgeon used the pegs to complete the procedure.No patient impact or adverse events have been reported as a result of the packaging malfunction.It was reported that no further information is available.
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.Visual evaluation of the returned product found the inner sterile pouches are broken into multiple pieces.Evaluation of the outer pouch found no damage.Sterility has not been breached.This complaint has been confirmed by evaluation of the returned product.The device history record was reviewed and no discrepancies relevant to the reported event were found.The condition of the device when it left zimmer biomet is considered conforming to specification.The root cause of the reported event cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: VANGUARD FEM PEGS SET 2
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16753475
• Report Number: 0001825034-2023-00813
• Device Sequence Number: 14310029
• Product Code: JWH
• UDI-Device Identifier: 00880304447646
• UDI-Public: (01)00880304447646(17)260811(10)148210
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K113550
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2023

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: 08/11/2026
• Device Model Number: 183099
• Device Catalogue Number: 183099
• Device Lot Number: 148210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 03/22/2023
• Supplement Date Received by Manufacturer: 06/05/2023
• Initial Report FDA Received Date: 04/17/2023
• Supplement Report FDA Received Date: 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2016
• 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: Prefer Not To Disclose