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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a breakage of a femoral pin which is used to attach the femoral navitracker.The tip of the pin remained in the patient's femur.Attempts are being made and additional information the reported event is unavailable at this time.
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Report source: foreign country (b)(4).An investigation into this incident is currently underway.Oncec the investigation has been completed and the results are made available, a follow up mdr will be submitted.Part of the device remains in patient.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.As the pin was not returned to zimmer biomet for analysis, a technical review and physical evaluation was not possible.A review of the dhr for the device did not identify any contributory factors.X-ray images were provided and sent to an independent medical professional (mmi) for review.Assessment of the imaging identified a possible retained foreign body within what appears to be the femoral cortex, confirming the reported event.A possible v-shaped metallic focus was also seen within the soft tissue.A definitive root cause is unable to 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: updated: d9, h6 the pin was returned for investigation.The head of the pin is missing with damage consistent with the reported event and the x-ray provided for investigation.Inspection of the part returned was unable to find the cause of the issue.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 available at the time of this report.

• Brand Name: CAS FIX PIN FLTD 3.2D X 150MM
• 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: kristen lashley ; 56 e. bell dr.; warsaw, IN 46582 ; 9016334069
• MDR Report Key: 15714056
• Report Number: 0009617840-2022-00028
• Device Sequence Number: 20057903
• Product Code: OLO
• UDI-Device Identifier: 00889024563629
• UDI-Public: (01)00889024563629(10)65407942
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K071929
• 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): 09/30/2025

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 Model Number: N/A
• Device Catalogue Number: 20-8000-000-01
• Device Lot Number: 65407942
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2022
• Supplement Date Received by Manufacturer: 04/27/2023; 09/29/2025
• Initial Report FDA Received Date: 11/02/2022
• Supplement Report FDA Received Date: 05/08/2023; 09/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2022
• 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: 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male