MAUDE Adverse Event Report: ACUMED PLATING SYSTEM; PLATE, FIXATION, BONE

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/03/2017

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2017, during an initial acetabular fixation procedure of the left acetabulum, a synthes 2.8mm threaded guide wire 450mm/trocar point/300mm calibration broke off.The surgeon reduced the fracture with a competitor's plating system.When removing the guide wire approximately one ( 1) centimeter of the threaded portion of the wire broke off.The fragment was left in the patient.No medical intervention was performed.There was no additional patient harm or surgical delay.The procedure was completed successfully.Patient outcome is stable.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PLATING SYSTEM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): ACUMED
• MDR Report Key: 17534564
• MDR Text Key: 321076465
• Report Number: MW5141465
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1