MAUDE Adverse Event Report: ZIMMER CAS CAS FIX PIN 3.2D X 80MM STR; 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	10/31/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported when removing the 80mm pin toward the end of the surgery from the tibia, the tip snapped off and remained in the bone.Approximately 5mm of the tip remained in the patient.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).G2: foreign country: new zealand.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.H3 other text : pin is not available for return.
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 device was not returned for investigation.As such, a physical and technical evaluation of the device could not be performed.The picture provided confirmed that the tip of one of the pins had been broken.No x-rays were available.Device history record review identified no deviation and/or anomalies related to the reported complaint event.The root cause of the broken pin could not be determined with the information available.Possible contributing factors are excessive force and/or off-angle application during insertion/removal of the pin.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 80MM STR
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): ZIMMER CAS; 75 queen str.; suite 3300; montreal, quebec H3C 2 N6; CA H3C 2N6
• 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: 18229176
• Report Number: 0009617840-2023-00020
• Device Sequence Number: 6222310
• Product Code: OLO
• UDI-Device Identifier: 00889024563636
• UDI-Public: (01)00889024563636(17)271118(10)65729396
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2024

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: 20-8000-000-11
• Device Lot Number: 65729396
• 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: 10/31/2023
• Supplement Date Received by Manufacturer: 04/03/2024
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 04/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/30/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Unknown