MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC. CORRAIL EXTRACTOR

Device Problem Use of Device Problem (1670)

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

Event Date 03/21/2022

Event Type  malfunction  

Event Description

Screw broke off into stem when corrail size #12 extractor being used during surgery (femoral stem placement).Decision by surgeon to leave in broken off piece.It is used with corrail impactor.No harm.

• Brand Name: CORRAIL EXTRACTOR
• Type of Device: EXTRACTOR
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC.; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 15326879
• MDR Text Key: 298978462
• Report Number: 15326879
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/29/2022,08/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/29/2022
• Date Report to Manufacturer: 08/31/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/31/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1