MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII MIS DCF ALIGN GDE; PRSTHSS,KNEE,FEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,METAL/POLYMER

Model Number 71441144

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 06/19/2020

Event Type  malfunction  

Event Description

It was reported that during tka surgery the locking mechanism on genesis ii mis dcf align gde broke.This happened inside the patient.No delay reported.Procedure could be finished using a s&n back up device.

Event Description

It was reported that during tka surgery the locking mechanism on gii mis dcf align gde7 did not worked.This happened during use inside the patient.No broken pieces to be found, locking mechanism just wouldn't lock anymore due to wear and tear.No delay reported.Procedure could be finished using a s&n back up device.

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 no serious injury- medical intervention has occurred since during procedure, the device did not broke and locking mechanism just did not work as it should due to wear and tear.Event determined to be a reportable malfunction.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.

Manufacturer Narrative

The device, intended use in treatment, was returned for evaluation.A functional evaluation concluded, the locking mechanism would not hold a grip to the block when engaged.A visual inspection confirmed device shows significant signs of wear/usage.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.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.This is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.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 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 MIS DCF ALIGN GDE
• Type of Device: PRSTHSS,KNEE,FEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10265135
• MDR Text Key: 198552286
• Report Number: 1020279-2020-03146
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 03596010497161
• UDI-Public: 03596010497161
• 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,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71441144
• Device Catalogue Number: 71441144
• Device Lot Number: 16EM09240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Date Manufacturer Received: 04/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention