MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VG 360 5N1 LK TIB TRL 63/67X10; INSTRUMENT, KNEE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2021
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
During the inspection of the loaner kit in the zb (b)(6) warehouse, it has been detected that the piece has arrived damaged, like bitten by an instrument.Not patient involved.No surgery occurred.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Upon reassessment of the reported event, it was determined to be not reportable as the product was determined to be worn, not fractured.The initial report was forwarded in error and should be voided.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The dhr was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause 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.
Event or Problem Description
Upon reassessment of the reported event, it was determined to be not reportable as the product was determined to be worn, not fractured.The initial report was forwarded in error and should be voided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d9; g1; g3; g6; h1; h2; h3; h6; h10 visual examination of the returned device found signs of repeated use and has a piece fractured off the posterior of the distal surface.The device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause 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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: VG 360 5N1 LK TIB TRL 63/67X10
• Common Device Name: INSTRUMENT, KNEE
• 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: 12371024
• Report Number: 0001825034-2021-02516
• Device Sequence Number: 17172542
• Product Code: JWH
• UDI-Device Identifier: 00880304515840
• UDI-Public: (01)00880304515840(11)190427(10)784850
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K093293
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/19/2022

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: N/A
• Device Catalogue Number: 32-360520
• Device Lot Number: 784850
• 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: 08/05/2021
• Supplement Date Received by Manufacturer: 01/05/2022; 07/19/2022
• Initial Report FDA Received Date: 08/26/2021
• Supplement Report FDA Received Date: 01/05/2022; 07/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• 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