MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MASTERLOC 01.39.10.0033 CALCAR REAMER LARGE ZIMMER HALL; HIP CALCAR REAMER LARGE ZIMMER HALL

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	12/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
During the primary hip surgery, a femoral bone fracture occurred while reaming the calcar with the calcar reamer large zimmer hall.The surgery was completed successfully.Nothing was done to the fracture, as it was "contained" and the surgeon did not feel that a cable or plate was necessary.
Additional Manufacturer Narrative
Batch review performed on 22-dec-2023.Lot 1951719: (b)(4) items manufactured and released on 25-nov-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.

• Brand Name: MASTERLOC 01.39.10.0033 CALCAR REAMER LARGE ZIMMER HALL
• Common Device Name: HIP CALCAR REAMER LARGE ZIMMER HALL
• 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: 18501924
• Report Number: 3005180920-2023-01094
• Device Sequence Number: 7811560
• Product Code: LXH
• UDI-Device Identifier: 07630040763790
• UDI-Public: 07630040763790
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: D040025
• 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): 01/12/2024

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: 1951719
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2023
• Initial Report FDA Received Date: 01/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/15/2019
• 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: 65 YR
• Patient Sex: Male