MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REFLECTION REAMER DOME 57MM; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Model Number 71362757

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/14/2020

Event Type  malfunction  

Event Description

It was reported that, during thr procedure, the "+" where the reamer dome 57 mm connects to the reamer shaft broke off.The procedure was finished using a smith and nephew backup device.Surgery was not delayed.The patient was not harmed beyond the described event.

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 reamer shaft had separated from the reamer.The device was manufactured in 2019 and shows signs of extensive use.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 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 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: REFLECTION REAMER DOME 57MM
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10526105
• MDR Text Key: 206712604
• Report Number: 1020279-2020-04569
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 03596010456953
• UDI-Public: 03596010456953
• 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: 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71362757
• Device Catalogue Number: 71362757
• Device Lot Number: 19CM13861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2020
• Date Manufacturer Received: 09/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention