MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CALCAR REAMER LARGE ZIMMER HALL; SURGICAL HIP INSTRUMENT

Catalog Number	01.39.10.0033
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs department.According to report, during calcar reaming, the calcar reamer caught on x-acta broach which caused it to torque and resulted in a longitudinal proximal femur fracture.From the radiographic image, cables that were used to reduce the fracture are visible.The instruments were all in good condition with no deformation/ damage present.It may be possible that the force applied was off axis or some external debris got caught between the hollow shaft and the spigot and caused the jamming.The chosen stem is cemented and therefore the fracture should not be cause of delayed osteointegration, so that full recovery can be expected.Note: the other component involved in the complaint is an x-acta broach, a device not registered in usa.However, the instrument used with the broach (01.39.10.0033 calcar reamer large zimmer hall) is registered in usa and can be used also with other broaches, registered in usa.
Event or Problem Description
During calcar reaming the, calcar reamer caught on x-acta broach which caused it to torque and resulted in a longitudinal proximal femur fracture.Cables were used to reduce the fracture.The surgeon was using axial force with the calcar reamer on power.He suspects the force may have been off axis and the teeth of the calcar reamer came into contact with the proximal part of the broach.The instruments were all in good condition with no deformation/ damage present.

• Brand Name: CALCAR REAMER LARGE ZIMMER HALL
• Common Device Name: SURGICAL HIP INSTRUMENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 19582673
• Report Number: 3005180920-2024-00423
• Device Sequence Number: 7392694
• Product Code: LXH
• UDI-Device Identifier: 07630040763790
• UDI-Public: 07630040763790
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/21/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 01.39.10.0033
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2024
• Initial Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female