MAUDE Adverse Event Report: DEPUY SYNTHES; PROSTHESIS, RADIAL HEAD

Model Number 02402224

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 10/15/2015

Event Type  malfunction  

Event Description

The head of radial head trial screw broke off while being placed in the patient.The piece was removed and final x-rays were taken to determine all pieces were out.

• Type of Device: PROSTHESIS, RADIAL HEAD
• Manufacturer (Section D): DEPUY SYNTHES; 1210 ward ave; west chester PA 19380
• MDR Report Key: 5318017
• MDR Text Key: 34102428
• Report Number: 5318017
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/16/2015,12/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 02402224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2015
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/16/2015
• Event Location: Hospital
• Date Report to Manufacturer: 10/16/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 25 YR