MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM AMIS MOBILE LEG POSITIONER 2.0 FRAME; SURGICAL INSTRUMENT FOR HIP SURGERY

Catalog Number	01.15.10.0190
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 06-august-2019: lot 1213731a: 1 item manufactured and released on 7 december 2017.No anomalies found related to the issue.
Event or Problem Description
Per-operative tibia fracture around diaphysis discovered after the tha surgery with amis mobile leg positioner.The cause of the fracture might be considered that the operation procedure of external rotation and hyperextension by the leg positioner.The patient knee was immobilized with the casts.No additional surgery was planned.

• Brand Name: AMISTEM AMIS MOBILE LEG POSITIONER 2.0 FRAME
• 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: 8925251
• Report Number: 3005180920-2019-00706
• Device Sequence Number: 2128390
• Product Code: LXH
• UDI-Device Identifier: 07630040735773
• UDI-Public: 07630040735773
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 08/23/2019

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: 01.15.10.0190
• Device Lot Number: 1213731A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2019
• Initial Report FDA Received Date: 08/23/2019
• 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; Required Intervention
• Patient Weight: 53