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

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the femoral array pins (150mm cas pins) got stuck in the patient's femur and broke when surgeon attempted to remove them.Xray was taken and surgeon decided to leave the pins in the femur and not attempt a removal.Surgeon noted that wire driver used to insert and remove pins was faulty.Unsure what caused the pins to break.No additional information available.
Additional Manufacturer Narrative
(b)(4).D10: 20-8000-000-10- cas fix pin 3.2d x 150mm str 2pk- 66740203.G2: foreign ¿ australia.The customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains in patient.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.The following sections were updated/corrected.Updated: d4; g3; h2; h4; h6.The reported event was confirmed via x-ray reviewed by a health care professional.The provided x-ray confirms two fractured surgical pin fragments present within the distal femur.The lot numbers of the devices were 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; therefore, it is not expected that the manufacturing process contributed to the reported issue.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.
Event or Problem Description
No further information is available regarding the reported event.

• 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: kristen lashley ; 56 e. bell dr.; warsaw, IN 46582 ; 9016334069
• MDR Report Key: 21039573
• Report Number: 0009617840-2024-00017
• Device Sequence Number: 12910125
• Product Code: OLO
• UDI-Device Identifier: 00889024563629
• UDI-Public: (01)00889024563629(17)290310(10)66585443
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2025

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: 20-8000-000-10
• Device Lot Number: 66585443
• Was Device Available for Evaluation?: Yes
• 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: 12/03/2024
• Supplement Date Received by Manufacturer: 04/18/2025
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 04/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/30/2024
• 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
• 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 Sex: Unknown