MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMIS SHOE; SURGICAL INSTRUMENT FOR HIP SURGERY

Catalog Number	01.15.10.0071
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	06/20/2019
Type of Reportable Event	Malfunction
Event or Problem Description
3 weeks after primary the patient complained a lateral ankle injury (minor ankle fracture).The surgical step in which the trauma has been generated is unknown.During the primary the medacta old style boot has been used.

• Brand Name: AMIS SHOE
• Common Device Name: SURGICAL INSTRUMENT FOR HIP SURGERY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8793308
• Report Number: 3005180920-2019-00586
• Device Sequence Number: 18916153
• Product Code: LXH
• UDI-Device Identifier: 07630040734950
• UDI-Public: 07630040734950
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/16/2019

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 01.15.10.0071
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2019
• Initial Report FDA Received Date: 07/16/2019
• 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