MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LOW PROFILE BROACH HANDLE; PROSTHESIS,HIP,SEMI-CONSTRAINED,METAL/POLY,CEMENT

Model Number 71364021

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/30/2020

Event Type  malfunction  

Event Description

It was reported that the broach's handle was loose, while inside the patient.No delay reported.No patient injuries reported.An s&n backup was available.

Manufacturer Narrative

The device, intended use in treatment, was not returned for evaluation, the reported event could not be confirmed.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.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.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.

• Brand Name: LOW PROFILE BROACH HANDLE
• Type of Device: PROSTHESIS,HIP,SEMI-CONSTRAINED,METAL/POLY,CEMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10747513
• MDR Text Key: 213447174
• Report Number: 1020279-2020-05882
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 03596010479112
• UDI-Public: 03596010479112
• 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
• Report Date: 12/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71364021
• Device Catalogue Number: 71364021
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 12/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1