MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FEMORAL IMPLANT IMPACTOR; PROSTHESIS,HIP,FEMORALCOMPONENT,CEMENTED,METAL

Model Number 71440005

Device Problems Fracture (1260); Unstable (1667)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/17/2020

Event Type  malfunction  

Event Description

It was reported that during procedure while instrument was outside the patient the bumpers for the femoral condyles are loose and will not tighten.No damage to patient, nothing fell into patient, all pieces recovered.The procedure was completed with an smith&nephew backup device.

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 cover on the cam arms are peeling off the device, rendering the device inoperable.The device was manufactured in 2010 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.

Event Description

It was initially reported that, during procedure while instrument was outside, the patient the bumpers for the femoral condyles were loose and will not tighten.The procedure was completed with an smith&nephew back-up device.Surgery was not delayed.Patient was not harmed.The investigation performed by the manufacturer revealed that the cover on the cam arms are peeling off the device, rendering the device inoperable.This is deemed a reportable malfunction.

Manufacturer Narrative

Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that there is no evidence that the same failure mode has triggered to a serious injury in the past, therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: FEMORAL IMPLANT IMPACTOR
• Type of Device: PROSTHESIS,HIP,FEMORALCOMPONENT,CEMENTED,METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10682655
• MDR Text Key: 211436428
• Report Number: 1020279-2020-05413
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 00885556034156
• UDI-Public: 00885556034156
• Combination Product (y/n): N
• 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: 12/01/2020

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: 71440005
• Device Catalogue Number: 71440005
• Device Lot Number: 10JM14068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2020
• Initial Date Manufacturer Received: 09/18/2020
• Initial Date FDA Received: 10/15/2020
• Supplement Dates Manufacturer Received: 09/18/2020; 11/13/2020
• Supplement Dates FDA Received: 11/05/2020; 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1