MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF CUP POSITIONER/IMPACTOR; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Model Number 71362299

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 09/24/2020

Event Type  malfunction  

Event Description

It was reported that before washing in the sterilization department it was noticed that the orange ball did not come off normally.There was a metal burr at the tip of the thread, heavy force was necessary to remove the orange bal.No delay.No patient involved.

Manufacturer Narrative

It was reported that before washing in the sterilization department it was noticed that the orange ball did not come of normally.There was a metal burr at the tip of the thread, heavy force was necessary to remove the orange ball.No patient involved.The associated device, intended for use in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.Photos were provided, which confirmed the stated failure.The tip of the instrument is deformed.A relationship, if any, between the device and the reported incident is corroborated.Our investigation including a review of manufacturing records did not reveal any deviation from the standard manufacturing processes.A review of the complaint history on the listed part revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no 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.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: REF CUP POSITIONER/IMPACTOR
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10702649
• MDR Text Key: 212047924
• Report Number: 1020279-2020-05560
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 03596010443236
• UDI-Public: 03596010443236
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71362299
• Device Catalogue Number: 71362299
• Device Lot Number: 08MM20056
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1