MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII FEM LUG PUNCH; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 71440183

Device Problem Break (1069)

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

Event Date 12/02/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during use in a total knee arthroplasty the genesis ii fem lug punch broke.No injury or delay reported.The procedure was finished using a smith and nephew backup device.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

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 lug punch is fractured, rendering the device inoperable.The device also shows signs of extensive use.A review of complaint history did not reveal additional complaints for the listed batch.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 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.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: GII FEM LUG PUNCH
• 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: 11083220
• MDR Text Key: 224021827
• Report Number: 1020279-2020-07837
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 03596010329868
• UDI-Public: 03596010329868
• 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: 10/12/2021

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: 71440183
• Device Catalogue Number: 71440183
• Device Lot Number: 06EM19188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2021
• Initial Date Manufacturer Received: 12/02/2020
• Initial Date FDA Received: 12/28/2020
• Supplement Dates Manufacturer Received: 10/11/2021
• Supplement Dates FDA Received: 10/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1