MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DBL OFFSET BROACH HDLE LT; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Model Number 71360089

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Patient Involvement (2645)

Event Date 07/02/2020

Event Type  malfunction  

Event Description

It was reported that the double offset broach handle left is worn/loose.There was no case involved.

Manufacturer Narrative

The associated device, intended for use in treatment, was returned and evaluated.A visual inspection of the returned device could not confirm the stated failure mode.The device was manufactured in 2017 and shows signs of extensive use.A functional evaluation was performed on the device and confirmed the stated failure mode.The device will no longer securely lock onto its mating part as designed rendering the device inoperable.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 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: DBL OFFSET BROACH HDLE LT
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10349376
• MDR Text Key: 201159532
• Report Number: 1020279-2020-03594
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 03596010610355
• UDI-Public: 03596010610355
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 12/17/2020

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
• Device Operator: Health Professional
• Device Model Number: 71360089
• Device Catalogue Number: 71360089
• Device Lot Number: 17AM16485
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/02/2020
• Initial Date FDA Received: 07/31/2020
• Supplement Dates Manufacturer Received: 07/02/2020
• Supplement Dates FDA Received: 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1