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

Model Number	N/A
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	05/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during a knee arthroplasty that when the sterile packaging was opened for the femoral pegs, the inner sterile bags were identified to be torn.Another package of femoral pegs was opened; however, the second set of inner sterile bags were also identified to be torn.As no additional femoral pegs were available, the second set was used to complete the procedure.No adverse events were reported as a result of this malfunction.
Additional Manufacturer Narrative
(b)(4).D10 - concomitant devices - vanguard femoral pegs set of 2 catalog #: 183099 lot #: 368890 g2 - report source - foreign: event occurred in japan.The complainant 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.Multiple mdr reports were filed for this patient; please see all reports associated with this event: 0001825034-2023-01226 h3 other text : investigation incomplete.
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.D9 - only the complaint inner packaging was returned for evaluation.No implants or outer packaging were received for review.The inner packaging was received on july 17, 2023.Visual evaluation of the returned packaging identified that the inner sterile pouches were broken into multiple pieces; however, sterility was not breached.The device history records were reviewed and no discrepancies were identified.The condition of the device when it left zimmer biomet was considered conforming to specification.A definitive root cause could not be determined with the information provided.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: VANGUARD FEMORAL PEGS SET OF 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: 17029804
• Report Number: 0001825034-2023-01225
• Device Sequence Number: 6909129
• Product Code: JWH
• UDI-Device Identifier: 00880304447646
• UDI-Public: (01)00880304447646(17)260829(10)443050
• 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): 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 Expiration Date: 08/29/2026
• Device Model Number: N/A
• Device Catalogue Number: 183099
• Device Lot Number: 443050
• 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: 05/12/2023
• Supplement Date Received by Manufacturer: 08/31/2023
• Initial Report FDA Received Date: 05/31/2023
• Supplement Report FDA Received Date: 09/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2016
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Patient Sex: Prefer Not To Disclose