MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PATELLAR REAMER SHAFT; PRSTHSIS, KNEE, PTLL/FMRTL, SM-CNSTRND, UNCNTD, PRS, CTD, PLYMR/MTL/PLYMR

Model Number 71440324

Device Problem Insufficient Information (3190)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported that during inspection it was found that the cutter handle does not fix the cutter baskets.The tibial cutting blocks left and right do not fit on the extramed.Also, the tibial alignment rods.This was noted during inspection.

Manufacturer Narrative

Results of investigation: the associated device, intended for use in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The locking mechanism on the device is seized, rendering the device inoperable.The device was manufactured in 2018 and shows signs of extensive use.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.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.

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 2018 and shows signs of extensive use.A functional evaluation of the returned device confirms the stated failure mode.The locking mechanism on the device is worn, rendering the device inoperable.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.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: GII PATELLAR REAMER SHAFT
• Type of Device: PRSTHSIS, KNEE, PTLL/FMRTL, SM-CNSTRND, UNCNTD, PRS, CTD, PLYMR/MTL/PLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10445404
• MDR Text Key: 204160647
• Report Number: 1020279-2020-04161
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 03596010214997
• UDI-Public: 03596010214997
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71440324
• Device Catalogue Number: 71440324
• Device Lot Number: 18FSY0010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2020
• Date Manufacturer Received: 12/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1