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 Injury (2348)

Event Date 02/07/2019

Event Type  Injury  

Event Description

It was reported that during surgery, the tips of the pointed reduction forceps became misaligned resulting in inadequate reduction of bone fragment.No delay, had backup.

Manufacturer Narrative

The associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The holding tips were bent, rendering the device inoperable.The device was manufactured in 2017 and exhibits signs of significant wear/ usage.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.The clinical / medical evaluation concluded that, based solely on the product evaluation, the root cause of the misalignment was likely due to wear /usage.Since there was no delay or alleged harm to the patient, no further clinical/medical assessment is warranted at this time.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• 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: 8384238
• MDR Text Key: 137654790
• Report Number: 1020279-2019-00889
• 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: 04/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71173377
• Device Lot Number: 16GTCD054
• Initial Date Manufacturer Received: 02/08/2019
• Initial Date FDA Received: 03/02/2019
• Supplement Dates Manufacturer Received: 02/08/2019
• Supplement Dates FDA Received: 04/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention