MAUDE Adverse Event Report: ZIMMER CAS CAS FIX PIN 3.2D X 80MM STR; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: united kingdom.Customer has indicated that the product will not be returned to zimmer biomet for investigation, retained by patient.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.H3 other text : retained by patient.
Event or Problem Description
It was reported patient underwent an initial rosa knee procedure.After the procedure, the trackers were removed, and a small piece of the 80 mm fix fluted pin had broken off and was believed to have remained in the patient¿s posterior cortex.The broken tip measured around 1mm.The surgeon expressed no concern and did not feel an xr was needed.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b1; b5; d4; g3; h1; h2; h3; h4; h6 the reported product was not returned to product surveillance for evaluation as it was discarded by the hospital.No investigation log was requested as an analysis of the logs would not contain any information that would help pinpointing the root cause of the reported fracture.Furthermore, no radiographs, photographs, or returned product were received for this complaint event.Follow-up communications confirmed that there was no foreign material left in the patient after review of an x-ray.Device history record (dhr) was reviewed for any deviations and/or anomalies in the production/manufacturing process that may have contributed to this reported event.No deviations or anomalies were discovered; therefore, it is not expected that the production/manufacturing process contributed to the reported issue.With the information currently available, a definitive root cause for the fracture of the pin cannot be determined and the complaint event cannot be confirmed at this time.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
It was reported that a sales representative met with the surgeon approximately 1-month post-procedure to review the reported case and x-ray.During the review, they confirmed that there was no sign of any fractured pieces remaining in the patient.No additional information available.

• Brand Name: CAS FIX PIN 3.2D X 80MM STR
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): ZIMMER CAS; 75 queen str.; suite 3300; montreal, quebec H3C 2 N6; CA H3C 2N6
• Manufacturer (Section G): ZIMMER CAS; 75 queen str.; suite 3300; montreal, quebec H3C 2 N6; CA H3C 2N6
• Manufacturer Contact: kristen lashley ; 56 e. bell dr.; warsaw, IN 46582 ; 9016334069
• MDR Report Key: 19033178
• Report Number: 0009617840-2024-00001
• Device Sequence Number: 15201620
• Product Code: OLO
• UDI-Device Identifier: 00889024563636
• UDI-Public: (01)00889024563636(17)280419(10)65999827
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K210121
• 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): 12/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 20-8000-000-11
• Device Lot Number: 65999827
• 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: 03/08/2024
• Supplement Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 04/03/2024
• Supplement Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2023
• 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: NI
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 66 YR
• Patient Sex: Male