MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY UNI TIB TR INS SZ5-6/8MM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	71436137
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during a ukr surgery, while using a journey uni tib tr ins sz5-6/8mm, a piece of plastic broke from its underside.The broken piece was retrieved with forceps and accounted for.The procedure was resumed, without any delay, using the same device.No injury was reported due to this issue.
Additional Manufacturer Narrative
Results of investigation: the shipping information was provided and all efforts were made to locate the device, however the subject device was not made available to the designated complaint unit and thus a physical product evaluation could not be performed.However, the photograph was reviewed, and revealed that the device is fractured.The device shows signs of use.The clinical/medical investigation concluded that, this case reports the broken piece of plastic from its underside of the journey uni tib tr ins sz5-6/8mm was retrieved with forceps and accounted for.Based on the limited information provided the root cause of the reported breakage could not be determined.Per the report, the surgeon completed the surgery without a delay using the same device.According to the report, there were no patient injuries or adverse consequences were reported.Therefore, no further medical assessment can be rendered at this time.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history based on the historical data revealed a similar event for the listed batch, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of instructions for use for care, maintenance, cleaning and sterilization of smith & nephew orthopedics devices revealed that visually inspecting for damage or wear, including components in their disassembled state prior to re-assembly as well as ensuring components are re-assembled securely is indicated.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely potential factors that could contribute to 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 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.Corrected data: b1 (type of event), b2 (no choices selected), g2 (report source).
Additional Manufacturer Narrative
The associated device was returned and evaluated.A visual inspection of the returned device reveals pieces of the device broke off.The pieces were not returned.A review of complaint history based on the historical data revealed a similar event for the listed batch, this failure mode will be monitored for future complaints for any necessary corrective actions.The clinical/medical evaluation concluded that this case reports the broken piece of plastic from its underside of the journey uni tib tr ins sz5-6/8mm was retrieved with forceps and accounted for.Based on the limited information provided the root cause of the reported breakage could not be determined.Per the report, the surgeon completed the surgery without a delay using the same device.According to the report, there were no patient injuries or adverse consequences were reported.Therefore, no further medical assessment can be rendered at this time.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 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.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.A review of instructions for use for care, maintenance, cleaning and sterilization of smith & nephew orthopedics devices revealed that visually inspecting for damage or wear, including components in their disassembled state prior to re-assembly as well as ensuring components are re-assembled securely is indicated.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely potential factors that could contribute to 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 future complaints and investigate as necessary.Internal complaint reference number: case (b)(4).

• Brand Name: JOURNEY UNI TIB TR INS SZ5-6/8MM
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 16728308
• Report Number: 1020279-2023-00801
• Device Sequence Number: 17817682
• Product Code: HSX
• UDI-Device Identifier: 03596010588142
• UDI-Public: 03596010588142
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K113038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/08/2023

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
• Operator of Device: Health Professional
• Device Model Number: 71436137
• Device Catalogue Number: 71436137
• Device Lot Number: 19EB00493
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2023
• Supplement Date Received by Manufacturer: 05/29/2023; 09/07/2023
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 06/01/2023; 09/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown