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

Model Number 71173377

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/12/2020

Event Type  malfunction  

Event Description

It was reported that during the procedure for the first time the reduction forceps w/ points broad were used in our evos mini tray, the point to point clamps bent at the point.Both clamps had this issue.30s surgical delay was reported.The backup device used was not from s+n.

Manufacturer Narrative

The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The holding tip on the device was broken/ bent, rendering the device inoperable.The device was manufactured in 2019 and show signs of moderate wear/usage.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.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 do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.These devices are reusable instruments that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; 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: 9927488
• MDR Text Key: 186604990
• Report Number: 1020279-2020-01161
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 03596010519535
• UDI-Public: 03596010519535
• Combination Product (y/n): N
• 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: 05/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71173377
• Device Catalogue Number: 71173377
• Device Lot Number: 19LTCD147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2020
• Date Manufacturer Received: 05/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1