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

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).A4: weight: 103 (unknown if kilograms or pounds).G2: foreign country: mexico.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the fractured pieces remain in the patient and the remainder of the devices were discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during a procedure using rosa, the first pin for navitrackers is placed in the femur, resulting in part of it being left inside (fractured piece).Radiological control is taken, an attempt is made to extract without success.A second attempt is made where for the second time, part of the pin is fragmented and remains inside, resulting in two fragments left in the patient.The doctor decides to continue with the procedure with rosa by placing both pins to attach navitrackers.There was a 30 (thirty) minute delay, attempting to extract the fragmented parts.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
No additional information on the reported event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Updated: g3; h2; h3; h4; h6.Corrected: a2, a4.Review of pictures provided observed two of the three pins displayed with the end point broken and confirming the reported event.Further, the attached mmi analysis of the provided x-ray pictures, the femur was examined using two spot images, revealing two fractured metallic pin remnants, one larger than the other, both appearing intraosseous.A new device with two pins was also observed on one image.Radiopaque fractured pin fragments were also observed.And confirm the reported event as that there are 2 retained fractured pin fragments within the femur as noted.No log analysis is required as the logs do not contain any information that would help pinpointing the root cause.Device history record (dhr) was reviewed, and no discrepancies were found.A definitive 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: CAS FIX PIN FLTD 3.2D X 150MM
• Common Device Name: ORTHOPEDIC STEROTAXIC 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: 19182186
• Report Number: 0009617840-2024-00004
• Device Sequence Number: 7147954
• Product Code: OLO
• UDI-Device Identifier: 00889024304185
• UDI-Public: (01)00889024304185(10)H211357
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 06/26/2024

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: 20-8000-000-01
• Device Lot Number: H211357
• 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: 04/09/2024
• Supplement Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 04/25/2024
• Supplement Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2023
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR
• Patient Sex: Unknown
• Patient Weight: 103 KG