MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CR TIBIAL ARTICULAR SURFACE PROVISIONAL LEFT SIZE 3-11 EF TOP; INSTRUMENT, KNEE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the instrument was found fractured when assembling the tray.There was no patient involvement.
Additional Manufacturer Narrative
(b)(4).The product has been received by zimmer biomet.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.H6: component code: mechanical (g04) - provisional top.Product was returned and evaluated.A visual inspection of the returned product found signs of repeated use along with nicks and gouges.The medial feature had small wedges fractured off the edge.The reported event is not related to a combination of products; therefore, a compatibility review is not applicable.The reported event did not occur in an operating room or as part of a medical procedure; medical records are not available for review.A review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The reported issue was confirmed via product review.A definitive root cause cannot be determined; however, a review of previous investigations for complaints associated with the tibial articular surface provisional (tasp) fracture was completed.Fractured tasps were analyzed by optical microscopy revealing hackle marks and river lines in the case of bending overload; and hackle marks, river lines and striations were found in the case of low cycle fatigue culminating in a bending overload failure type.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.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: CR TIBIAL ARTICULAR SURFACE PROVISIONAL LEFT SIZE 3-11 EF TOP
• Common Device Name: INSTRUMENT, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18425328
• Report Number: 0001822565-2024-00007
• Device Sequence Number: 18170005
• Product Code: JWH
• UDI-Device Identifier: 00889024238503
• UDI-Public: (01)00889024238503(10)63722740
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K113369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2024

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: 42517000510
• Device Lot Number: 63722740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2023
• Supplement Date Received by Manufacturer: 01/11/2024
• Initial Report FDA Received Date: 01/02/2024
• Supplement Report FDA Received Date: 01/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2017
• 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: Unknown
• 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