MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. MORELAND; EVACUATOR, VAPOR, CEMENT MONOMER

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/08/2019

Event Type  malfunction  

Event Description

Part of the ringed curette broke off in patient's left lower leg.

• Brand Name: MORELAND
• Type of Device: EVACUATOR, VAPOR, CEMENT MONOMER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic dr.; warsaw IN 46582
• MDR Report Key: 8361200
• MDR Text Key: 136853017
• Report Number: 8361200
• Device Sequence Number: 1
• Product Code: JDY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/15/2019
• Event Location: Hospital
• Date Report to Manufacturer: 02/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 15695 DA