MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CORKSCREW FEM HEAD REMOVER; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 71930020

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/26/2020

Event Type  malfunction  

Event Description

It was reported that during a thr surgery was noticed that the tip of the corkscrew fem head remover is no longer sharp and is bent.The procedure was finished using a smith and nephew back up device, with no surgical delay and no injury to the patient.

Manufacturer Narrative

The device, used in treatment, was returned for evaluation.A visual inspection confirms the tip of the device is dull and bent.The device shows significant signs of wear/usage.The device was manufactured in 2016.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality 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.Expected wear/tear is likely the probable cause 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 complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: CORKSCREW FEM HEAD REMOVER
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10280407
• MDR Text Key: 199043464
• Report Number: 1020279-2020-03244
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 00885556049709
• UDI-Public: 885556049709
• 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: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• 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: 16LM07650
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1