MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM BROACH SIZE 2; SURGICAL INSTRUMENT FOR HIP SURGERY

Catalog Number	01.18.10.102
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/29/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
After femoral rasping, the surgeon tried to reposition and felt an abnormal feeling.Checking the ct image has been discovered the transverse fracture about 10mm further than the distal rasping point.The surgeon fixed the fracture and cable.Due to this event, the surgery was prolonged about 2 hours.Total surgery time was about 4 hours.The rasp did not show any deformations or scratches.

• Brand Name: AMISTEM BROACH SIZE 2
• 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: 8939223
• Report Number: 3005180920-2019-00708
• Device Sequence Number: 2610171
• Product Code: LXH
• UDI-Device Identifier: 07630040751780
• UDI-Public: 07630040751780
• 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): 08/28/2019

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: 01.18.10.102
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2019
• Initial Report FDA Received Date: 08/28/2019
• 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: Required Intervention
• Patient Age: 54 YR
• Patient Weight: 58