MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RDCE FRCPS W/ PTS {} BRD; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number 71173377

Device Problem Failure to Align (2522)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/07/2019

Event Type  malfunction  

Event Description

It was reported that during surgery the tips of the pointed reduction forceps became misaligned resulting in inadequate reduction of bone fragments.No delay.No revision surgery performed.Backup device available.

Manufacturer Narrative

The associated complaint device was returned and evaluated.A visual examination of the reduction forceps indicated that the one of the points is bent, confirming the stated complaint.This device was manufactured in 2016.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A clinical analysis indicated that the root cause remains unknown based on the information received.There is no patient impact as the procedure was reportedly completed with a backup device with an ¿optimal outcome.¿ no further medical assessment is warranted at this time.Based on this investigation, the need for corrective action is not indicated.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: RDCE FRCPS W/ PTS {} BRD
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8395011
• MDR Text Key: 137971768
• Report Number: 1020279-2019-00916
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 03596010519535
• UDI-Public: 03596010519535
• Combination Product (y/n): N
• PMA/PMN Number: K123598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71173377
• Device Lot Number: 17MTCD032
• Date Manufacturer Received: 02/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1