MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CORKSCREW FEM HEAD REMOVER; PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY

Catalog Number 71930020

Device Problems Material Deformation (2976); Incomplete or Inadequate Connection (4037)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/11/2021

Event Type  malfunction  

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 device is stripped causing it to not attach properly, rendering it inoperable.The device was manufactured in 2018 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.

Event Description

It was reported that the femoral head remover will not stay securely attached to hudson adaptor.The event occurred during surgery and the procedure was completed using the same device.No surgical delay or injury to the patient was reported.After product evaluation was determined that the device is stripped causing it to not attach properly, rendering it inoperable.

Manufacturer Narrative

The device, used in treatment, was returned for evaluation.A visual inspection of the returned device confirmed the stated failure mode.The tip of the device was found to be stripped, rendering the device inoperable.The device shows signs of extensive use.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: CORKSCREW FEM HEAD REMOVER
• Type of Device: PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11722209
• MDR Text Key: 247262998
• Report Number: 1020279-2021-03449
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: K121393
• 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: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71930020
• Device Lot Number: 18LM06673
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2021
• Date Manufacturer Received: 06/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1