MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII ARTICULAR INSERTER/EXTRACT; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 71440194

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/15/2020

Event Type  Injury  

Event Description

It was reported that, during a tka, the articular inserter extractor tip broke upon insertion of the polyethylene insert onto the tibial implant.An alternate articular inserter from another genesis ii tray was utilized to successfully implant the insert implant.Delay reported less or equal than 30 minutes.The patient was not harmed.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that per complaint details, the device tip broke upon insertion during the procedure.Reportedly, the procedure was successfully completed using a backup s+n device within a 0-30 minute surgical extension.S+n has not received adequate documentation to fully evaluate the root cause of the reported event as responses to the clinical requests were not provided.The patient impact beyond the reported modified surgical procedure and 0-30 minute delay could not be determined, although a backup was reportedly utilized to successfully complete the procedure.No further medical assessment is warranted at this time.Should clinically relevant documentation/information become available, the clinical/medical task may be re-evaluated.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 have no 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 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.Without the return of the actual product involved or product information, our investigation could not proceed.Should the device or 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 ARTICULAR INSERTER/EXTRACT
• 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: 10681417
• MDR Text Key: 211422869
• Report Number: 1020279-2020-05395
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 03596010214393
• UDI-Public: 03596010214393
• 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
• Report Date: 06/23/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 71440194
• Device Catalogue Number: 71440194
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/16/2020
• Initial Date FDA Received: 10/14/2020
• Supplement Dates Manufacturer Received: 06/18/2021
• Supplement Dates FDA Received: 06/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention