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

Model Number	N/A
Medical Device Problem Codes	Tear, Rip or Hole in Device Packaging (2385); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Japan.Customer has indicated that the product will be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the distal femoral pegs fell out of the inner bags and compromised the sterility of the product.The procedure was completed with pegs from another package.Attempts to obtain additional information have been made; however, no more information is available.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.Visual evaluation of the returned product found the inner sterile pouches are broken into multiple pieces.Sterility has not been breached.This complaint has been confirmed by evaluation of the returned product.Medical records were not provided.Device history record (dhr) was reviewed for deviations and/ or anomalies with no deviations / anomalies identified.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 received 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: 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: 17118207
• Report Number: 0001825034-2023-01322
• Device Sequence Number: 20591216
• Product Code: JWH
• UDI-Device Identifier: 00880304447646
• UDI-Public: (01)00880304447646(17)261116(10)118750
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2023

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 Model Number: N/A
• Device Catalogue Number: 183099
• Device Lot Number: 118750
• 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: 05/19/2023
• Supplement Date Received by Manufacturer: 08/31/2023
• Initial Report FDA Received Date: 06/13/2023
• Supplement Report FDA Received Date: 09/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2016
• 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: Unknown