MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 MIS X-BAR; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Model Number 71366052

Device Problem Solder Joint Fracture (2324)

Patient Problem No Patient Involvement (2645)

Event Date 06/11/2020

Event Type  malfunction  

Event Description

It was reported that device broke in weld area.No case involved.

Manufacturer Narrative

The device, intended for use in treatment, was returned for evaluation.A visual inspection confirms the weld that connects the alignment rod to the x-bar fractured.The x-bar is clamped to the r3 offset impactor during impaction of the r3 shell to aid in proper positioning/alignment of the shell.If sufficient forces are transferred to the alignment rod during impaction, bending moments and/or torque may be transferred to the weld area which may result in fracture of the weld due to repeated use.The fracture of the weld can likely be attributed to a combination of fatigue and static overload failure caused from repeated use.The device shows significant signs of wear/usage.This device was manufactured in 2010.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Expected wear/tear is likely the probable cause of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.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: R3 MIS X-BAR
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10244350
• MDR Text Key: 197976942
• Report Number: 1020279-2020-02990
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 03596010580207
• UDI-Public: 03596010580207
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/30/2020

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
• Device Operator: Health Professional
• Device Model Number: 71366052
• Device Catalogue Number: 71366052
• Device Lot Number: 10FM00261
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/11/2020
• Initial Date FDA Received: 07/08/2020
• Supplement Dates Manufacturer Received: 09/17/2020
• Supplement Dates FDA Received: 09/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1