MAUDE Adverse Event Report: ZIMMER CAS CAS FIX PIN 3.2D X 150MM STR 2PK; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	20-8000-000-10
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the remaining product will not be returned to zimmer biomet for investigation, as it was discarded.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 the cas fix pin broke off in patient's femur.The fragment was not retrieved and remains in the patient.There have been no reports of medical intervention due to this.Attempts have been made and additional information on the reported event is unavailable at this time.
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 following sections were {update/corrected} updated: d4, h4, h6.The pin was not returned for evaluation.Per the analysis of the provided x-ray pictures, the complaint was confirmed.The femur was examined using two views of the distal femur, revealing views of the distal femur demonstrate a knee arthroplasty.Metallic fragment within the posterior aspect of the distal femoral diaphysis.Air and fluid within the joint space suggests recent surgery.Metallic foreign body within the posterior aspect of the distal femoral diaphysis.The lot number of this device was reviewed for any deviations and/or anomalies in the manufacturing process that may have contributed to this reported event.No deviations or anomalies were discovered in the device history record; therefore, it is not expected that the manufacturing process contributed to the reported issue.Raw material review did not identify any related deviations or anomalies which would have caused or contributed to the reported event.A definitive root cause cannot be determined with the information available.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: CAS FIX PIN 3.2D X 150MM STR 2PK
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): ZIMMER CAS; 75 queen str.; suite 3300; montreal, quebec
• Manufacturer (Section G): ZIMMER CAS; 75 queen str.; suite 3300; montreal, quebec H3C 2 N6; CA H3C 2N6
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21460786
• Report Number: 0009617840-2025-00006
• Device Sequence Number: 7591567
• Product Code: OLO
• UDI-Device Identifier: 00889024563629
• UDI-Public: (01)00889024563629(17)290126(10)66953725
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K182964
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2025

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 Catalogue Number: 20-8000-000-10
• Device Lot Number: 66953725
• 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: 02/03/2025
• Supplement Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/10/2024
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Sex: Male
• Patient Weight: 100 KG