MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PS TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT SIZE 6-9 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)
Date of Event	10/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The product has been received by zimmerbiomet.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 receiving found parts with fractures in them.Rep states the event did occur during a procedure (initial hip).Nothing fell into patient and it did not affect the patient.Additional patient information is unavailable.(from product return/check in item shows fracture- not all pieces returned.).
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.The device history records & receiving inspection report was reviewed for deviations and / or anomalies with no deviations / anomalies identified.Verified item lot combination and reviewed manufacturing date as tasp exhibits signs of repeated use (nicked or gouged) and is chipped, not all pieces returned.Reference attached photos.Medical records were not provided.The summary of investigations for complaints associated with the tibial articular surface provisional (tasp) fracture.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.In addition to the visual and optical microscopy analysis, a review of the dhf and dfmea was performed.Ongoing complaint monitoring confirms that the rate of instrument fracture is within the expected risk profile as specified in the dfmea.Complaint confirmed.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.

• Brand Name: PS TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT SIZE 6-9 EF TOP
• 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: 12751098
• Report Number: 0001822565-2021-03195
• Device Sequence Number: 7083970
• Product Code: JWH
• UDI-Device Identifier: 00889024245334
• UDI-Public: (01)00889024245334(17)63863338
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2021

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: 42527400710
• Device Lot Number: 63863338
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2021
• 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: 10/13/2021
• Supplement Date Received by Manufacturer: 12/06/2021
• Initial Report FDA Received Date: 11/04/2021
• Supplement Report FDA Received Date: 12/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2018
• 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: Male