MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII MIS DCF AP CT BLK 6; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 71441154

Device Problem Naturally Worn (2988)

Patient Problem No Patient Involvement (2645)

Event Date 08/13/2020

Event Type  malfunction  

Event Description

It was reported that the gii mis dcf ap ct blk 6 is worn from excessive use.There was no case involved.No patient harm or surgical delay was reported.

Manufacturer Narrative

The device, intended for use in treatment, was returned for evaluation.A visual inspection of the returned cutting block confirms there are several burrs and gouges in the metal causing the stated failure.This device was manufactured in 2010.This device exhibits signs of significant wear/usage.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.

• Brand Name: GII MIS DCF AP CT BLK 6
• 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: 10518437
• MDR Text Key: 206474182
• Report Number: 1020279-2020-04534
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 03596010497222
• UDI-Public: 03596010497222
• 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: 09/24/2020

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: 71441154
• Device Catalogue Number: 71441154
• Initial Date Manufacturer Received: 08/13/2020
• Initial Date FDA Received: 09/10/2020
• Supplement Dates Manufacturer Received: 09/21/2020
• Supplement Dates FDA Received: 09/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1