MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM BROACH #00

Model Number	01.18.10.099
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2020 lot 1550898: 25 items manufactured and released on (b)(6) 2015.No anomalies found related to the problem to date, no other similar events have been reported.Clinical evaluation intraoperative femoral perforation in an elderly lady (88 years old).This event is likely due to a technical error but bone quality and morphology may also contribute.There is no reason to suspect a faulty device.
Event or Problem Description
After the femoral rasping and after that the surgeon was using the trial neck, a femur bone fracture was discovered.The surgeon, re-performed the rasping and completed the surgery successfully.No particular treatment has been performed as cerclage or the use of a cemented stem.

• Brand Name: AMISTEM BROACH #00
• Common Device Name: BROACH
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11028078
• Report Number: 3005180920-2020-00917
• Device Sequence Number: 16310722
• Product Code: LXH
• UDI-Device Identifier: 07630040751759
• UDI-Public: 07630040751759
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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): 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 01.18.10.099
• Device Catalogue Number: 01.18.10.099
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 12/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 88 YR