MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY TIBIAL IMPL IMPACTOR; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 74018901

Device Problem Break (1069)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/19/2020

Event Type  Injury  

Event Description

It was reported that during tka procedure, while inside the impactor was broken all pieces were retrieved.No delay reported.It is unknown how was the procedure completed.Patient injuries were not reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The device, used in treatment, was returned for evaluation.The clinical/medical team concluded, this case reports the impactor was found to be broken following usage inside the patient.Per email communication, the broken piece was retrieved, and the procedure was completed without patient injury or delay, using the same device.No further clinical assessment is warranted.A visual inspection confirmed the bumper is chipped on the journey tibial impl 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 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.

• Brand Name: JOURNEY TIBIAL IMPL IMPACTOR
• 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: 10819369
• MDR Text Key: 215606719
• Report Number: 1020279-2020-06354
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 03596010557285
• UDI-Public: 03596010557285
• 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: 01/08/2021

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: 74018901
• Device Catalogue Number: 74018901
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Initial Date Manufacturer Received: 10/20/2020
• Initial Date FDA Received: 11/10/2020
• Supplement Dates Manufacturer Received: 01/07/2021
• Supplement Dates FDA Received: 01/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention