MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SMS INSTRUMENTS 01.39.10.0034 CALCAR REAMER SMALL ZIMMER HALL; HIP CALCAR REAMER

Model Number	01.39.10.0034
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	10/27/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2022.Lot 1951642: 40 items manufactured and released on 07-aug-2019.No anomalies found related to the problem.To date, no other similar events have been reported on the same lot during the period of review.
Event or Problem Description
During the primary hip surgery, when the surgeon was using the small calcar planner, the anterior aspect of the femur split.The surgeon cabled the fracture and continued with the case.There was a 10-minute delay and the surgery was completed successfully.A consignment set was utilized.Reamer teeth were not worn, first time usage.Sms 9 std implanted (sms 9 std templated).

• Brand Name: SMS INSTRUMENTS 01.39.10.0034 CALCAR REAMER SMALL ZIMMER HALL
• Common Device Name: HIP CALCAR REAMER
• 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15864354
• Report Number: 3005180920-2022-00868
• Device Sequence Number: 12488063
• Product Code: LXH
• UDI-Device Identifier: 07630040763806
• UDI-Public: 07630040763806
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/25/2022

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 Model Number: 01.39.10.0034
• Device Catalogue Number: 01.39.10.0034
• Device Lot Number: 1951642
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2022
• Initial Report FDA Received Date: 11/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/07/2019
• 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: 56 YR
• Patient Sex: Male