MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SYN F/T BRCH SZ 13; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Model Number 71366709

Device Problems Nonstandard Device (1420); Dull, Blunt (2407); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/22/2020

Event Type  malfunction  

Event Description

It was reported that, after procedure, this broach was noticed to be dull and not true to size.The device had been used to complete the procedure and no issues were reported during case.

Manufacturer Narrative

The associated device, intended for use in treatment, was returned and evaluated.A visual inspection of the returned device was found to be dull.A dimensional evaluation of the returned device could not confirm the stated failure mode.The returned device passed overall tooth profile with overlay 005374.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.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.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: SYN F/T BRCH SZ 13
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10697002
• MDR Text Key: 211886821
• Report Number: 1020279-2020-05496
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 03596010429629
• UDI-Public: 03596010429629
• Combination Product (y/n): N
• PMA/PMN Number: K123598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 05/17/2021

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: 71366709
• Device Catalogue Number: 71366713
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2020
• Date Manufacturer Received: 05/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1