MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII MIS DCF AP CT BLK 5; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 71441153

Device Problem Component Missing (2306)

Patient Problem Injury (2348)

Event Date 05/28/2020

Event Type  Injury  

Event Description

It was reported that after procedure tka the surgeon did not notice the missing peg from the cutting block until postoperative x-ray (during the procedure the surgeon followed proper technique in placement and removal of the 4 in 1 cutting block).The procedure was completed without delay.

Manufacturer Narrative

H6: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device could not confirm the stated failure mode.The device has the components in question intact.The device shows signs of extensive use.A picture of a radiograph was provided that showed the broken component; however, this device was not returned with the others.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.A review of the risk management file revealed this failure mode was previously identified.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

Additional information based on the results of the investigation indicates that this complaint should be reassessed in terms of reportability.The new information reveals that the device corresponding to this complaint belongs to a different set of devices than the one initially reported and also does not present any failure related to the reported event.

• Brand Name: GII MIS DCF AP CT BLK 5
• 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: 10176747
• MDR Text Key: 195894495
• Report Number: 1020279-2020-02624
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 03596010497215
• UDI-Public: 03596010497215
• 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,Followup
• Report Date: 07/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71441153
• Device Catalogue Number: 71441153
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Initial Date Manufacturer Received: 05/28/2020
• Initial Date FDA Received: 06/19/2020
• Supplement Dates Manufacturer Received: 07/19/2021; 07/19/2021
• Supplement Dates FDA Received: 07/19/2021; 07/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention