MAUDE Adverse Event Report: ZIMMER CAS FIX PIN FLTD 3.2DX150MM 2 PACK; 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	02/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2 foreign: china it is unknown which item/lot number out of the following was used during the event: 00-5901-020-00 lot: 66160994.20-8000-000-10 lot: 66120666.20-8000-000-11 lot: 66120615.The device will not be returned for analysis; 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
After surgery, x ray shows the pin fractured into patient.Because of the postoperative results and patient satisfaction, it was communicated to the patient that there would be no revision to remove the fractured pin.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 updated/corrected.Updated: d4, h4, h5, h6.It is unknown which item/lot number out of the following was used during the event: part number: 20-8000-000-10 lot: 66120666.Part number: 00-5901-020-00 headless trocar drill pin 3.2 mm diameter 75 mm length lot: 66160994 ¿ product code: lxh - 510k: exempt ¿ udi : (b)(4) - manufacturing date: jul 20, 2023 ¿ expiration date: jul 17, 2033.Part number: 20-8000-000-11 fix pin fltd 3.2dx80mm 2 pack lot: 66120615 ¿ product code: olo - 510k: k182964 ¿ udi : (b)(4) - manufacturing date: oct 11, 2023 ¿ expiration date: jun 30, 2028.The product was not returned for evaluation.As per the analysis of the provided x-ray picture: there is a small radiodensity at the posterior cortex of the distal femoral diaphysis consistent with the retained fractured pin.Small retained pin fragment within the distal femoral diaphysis.Review of the device history records identified no deviations or anomalies related to the reported event.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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: FIX PIN FLTD 3.2DX150MM 2 PACK
• 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: 21682637
• Report Number: 0009617840-2025-00009
• Device Sequence Number: 8488485
• Product Code: OLO
• UDI-Device Identifier: 00889024563629
• UDI-Public: (01)00889024563629(17)280730(10)66120666
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2025

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: 66120666
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2025
• Supplement Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 03/24/2025
• Supplement Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/23/2023
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown