MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY UNI TIBIAL IMPACTOR; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 71441353

Device Problem Break (1069)

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

Event Date 05/18/2020

Event Type  Injury  

Event Description

It was reported that, during an uni-compartmental knee surgery, the plastic part of the impactor broke on the last bump.All of the fallen pieces were successfully retrieved from the patient.An s&n backup was not required.No delay reported.No patient injuries reported.

Manufacturer Narrative

The device, used in treatment, was returned for evaluation.The clinical/medical team concluded, per report all of the broken pieces were recovered.Photos were provided via e-mail which confirm the reported events.Although a twenty minute delay was noted, no patient injuries or adverse consequences were reported.Since no patient injuries are being reported no further clinical/medical assessment is warranted at this time.A visual inspection confirmed the threads are damaged on the medium hexdriver.The 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 review of complaint history for the listed part revealed no prior complaints for the listed batch.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.

Manufacturer Narrative

The device, used in treatment, was returned for evaluation.The clinical/medical team concluded, per report all of the broken pieces were recovered.Photos were provided via e-mail which confirm the reported events.Although a twenty minute delay was noted, no patient injuries or adverse consequences were reported.Since no patient injuries are being reported no further clinical/medical assessment is warranted at this time.A visual inspection confirmed the threads are damaged on the impactor.The 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 product failed to meet any product specifications at the time of manufacture.A review of complaint history for the listed part revealed no prior complaints for the listed batch.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.A review of risk management files found that the reported failure was documented appropriately.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.

Manufacturer Narrative

H3, h6: the device, used in treatment, was returned for evaluation.The clinical/medical team concluded, per report all of the broken pieces were recovered.Photos were provided via e-mail which confirm the reported events.Although a twenty minute delay was noted, no patient injuries or adverse consequences were reported.Since no patient injuries are being reported no further clinical/medical assessment is warranted at this time.A visual inspection of the returned journey uni tibial impactor confirms the plastic bumper has a piece missing.This piece was not returned with the device.The device shows signs of significant use and wear.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 review of complaint history for the listed part revealed no prior complaints for the listed batch.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.A review of risk management files found that the reported failure was documented appropriately.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: JRNY UNI TIBIAL IMPACTOR
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10172954
• MDR Text Key: 195708021
• Report Number: 1020279-2020-02589
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 03596010588050
• UDI-Public: 03596010588050
• Combination Product (y/n): N
• PMA/PMN Number: K113038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71441353
• Device Catalogue Number: 71441353
• Device Lot Number: 17FM10575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2020
• Date Manufacturer Received: 07/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention