MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM BROACH AMISTEM JAKOB SIZE 7; SURGICAL INSTRUMENT FOR HIP SURGERIES

Catalog Number	01.18.10.207
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 december 2018: lot 106268: (b)(4) items manufactured and released on 04-oct-2010.No anomalies found related to the problem.To date, another similar event was reported on this lot.Clinical evaluation performed by medical affairs director: intraoperative femoral fractures are known possible adverse events of total hip replacements, described and quantified in literature.They mainly depend on bone morphology and mechanical properties.In this case, there is no reason to suspect a malfunctioning device.
Event or Problem Description
During the primary hip surgery, while broaching the femur in order to implant the stem, the femur fractured.This "casued" a 10 minute delay in the case and the surgeon was able to cable the fracture.The reporter stated he was not certain on reason for fracture, but it occurred while broaching with the #7 broach.Type b femur; not certain on patient bone quality.

• Brand Name: AMISTEM BROACH AMISTEM JAKOB SIZE 7
• Common Device Name: SURGICAL INSTRUMENT FOR HIP SURGERIES
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8173611
• Report Number: 3005180920-2018-01009
• Device Sequence Number: 1279475
• Product Code: LXH
• UDI-Device Identifier: 07630040752053
• UDI-Public: 07630040752053
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/18/2018

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: 01.18.10.207
• Device Lot Number: 106268
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2018
• Initial Report FDA Received Date: 12/18/2018
• 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