MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II UK MED INSERT TRIAL SZ 3-4 9MM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	74036019
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal reference number: (b)(4).
Event or Problem Description
It was reported that during a tka, after using a jrny ii uk med insert trial sz 3-4 9mm, it was noticed that there was the yellow shavings into the patient body.The device was found to be shaved.The piece was removed with an unknown method and more cleaning than usual was done.There was a non-significant delay and the procedure was finished using the same device.Patient was not harmed.
Additional Manufacturer Narrative
H3, h6: the device was received for evaluation at the manufacturing site, but a physical product evaluation was not possible.However, the photographs were reviewed, and revealed that the device is scratched, worn and small pieces are fractured off the edges and surface.The clinical/medical investigation concluded that, the provided electronic photo/image (although the trial appears to have scuff-marks) does not provide insight into a clinical root cause of the reported event; however, the smith and nephew cleaning/sterilization/care guide specifically addresses the need for inspection and function and notes: ¿trials: articular surfaces should be smooth and free of cracks and deep nicks.¿ additionally, the limitations of processing notes: ¿improperly functioning devices, devices with unrecognizable markings, missing or removed (buffed off) part numbers, damaged and excessively worn devices should not be used.¿ it was communicated that the operative notes are unavailable.No clinical factors can be definitively concluded to have contributed to this reported event.Patient impact beyond the reported ¿yellow shavings¿ requiring ¿more cleaning than usual¿ with a 5-minute surgical delay cannot be determined based on the limited information provided.The current patient status is unknown, although no patient harm was reported.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 for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.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 evidence to conclude 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 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: JRNY II UK MED INSERT TRIAL SZ 3-4 9MM
• 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: 19711045
• Report Number: 1020279-2024-01338
• Device Sequence Number: 18337401
• Product Code: HSX
• UDI-Device Identifier: 00885556691427
• UDI-Public: 00885556691427
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K190085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 74036019
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2024
• Supplement Date Received by Manufacturer: 10/01/2024
• Initial Report FDA Received Date: 07/10/2024
• Supplement Report FDA Received Date: 10/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Female