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

Catalog Number	20800000010
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/26/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: foreign country: europe: romania.The device will not be returned for analysis, as the remainder of the pin is unavailable per hospital policy; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that at the end of the surgery, the surgeon wanted to remove the femoral pins.After he managed to remove the pin, he found that its tip was broken.He performed an x-ray and found that the broken tip remained in the bone.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 updated: a1 (unknown); d4; g4; h2; h3; h6.Review of the x-ray by a health care professional confirmed a retained broken-off metal guide pin present within the femur.The device history record was reviewed and no discrepancies relevant to the reported event were found.The 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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.A definitive root cause cannot be determined.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: CAS FIX PIN 3.2D X 150MM STR
• 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
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22201686
• Report Number: 0009617840-2025-00024
• Device Sequence Number: 17864209
• Product Code: OLO
• UDI-Device Identifier: 00889024563629
• UDI-Public: (01)00889024563629(17)300102(10)67034257
• Combination Product (Y/N): N
• Initial Reporter Country: RO
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2026

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: 20800000010
• Device Lot Number: 67034257
• 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: 05/26/2025
• Supplement Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2025
• 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
• Patient Sex: Unknown