MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 MIS X-BAR; PROSTHESISHIPFEMORALCOMPONENT,CEMENTED,METAL

Model Number	71366052
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The associated device, intended for use in treatment, was returned and evaluated. a visual inspection of the returned device confirmed the stated failure mode.The post of the device has completely broken off at the weld, rendering the device inoperative.The broken post was returned with the device.The device shows signs of extensive use. 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.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are 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 complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.
Event or Problem Description
It was reported that one r3 mis x-bar broke during wash.As this was noticed upon cleaning and sterilization activities, there was not patient involvement.

• Brand Name: R3 MIS X-BAR
• Common Device Name: PROSTHESISHIPFEMORALCOMPONENT,CEMENTED,METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12440865
• Report Number: 1020279-2021-06746
• Device Sequence Number: 4892106
• Product Code: JDG
• UDI-Device Identifier: 03596010580207
• UDI-Public: 03596010580207
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/08/2021

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
• Operator of Device: Health Professional
• Device Model Number: 71366052
• Device Catalogue Number: 71366052
• Device Lot Number: 09CM14487
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2021
• Initial Report FDA Received Date: 09/08/2021
• Patient Sequence Number: 1