MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II XR INS XLPE MED 3-4 LT 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/

Model Number	74023743
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference number: (b)(4).
Event or Problem Description
It was reported that during knee arthroplasty, the insert jrny ii xr ins xlpe med 3-4 lt 11mm broke.It is unknown how the procedure was finished and if there was any delay.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
Internal complaint reference number: (b)(4).
Event or Problem Description
It was reported that during knee arthroplasty the insert jrny ii xr ins xlpe med 3-4 lt 11mm broke inside the patient.All pieces were removed by hand.The procedure was completed with a less than or equal to 30 minutes delay using a smith and nephew back-up device.No other complications were reported.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that the procedure was completed with a backup device without retained foreign bodies/¿all pieces were removed¿.Although there was a 0-30 minute surgical delay, no patient injury or harm was reported.S+n recommends that all reusable instruments be routinely inspected for functionality/wear/damage and replaced as necessary.Since all fragments were removed and no patient injury was reported due to the reported event and/or surgical delay, no further medical assessment is warranted at this time.A review of complaint history did not reveal additional complaints for the listed batch.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 the risk management file and instructions for use documents revealed this failure mode and potential harm was previously identified.Possible causes could include but not limited to design of device, improper size of device used, lifetime of device, material in use, overuse, procedural/use error, traumatic injury, unclear use instructions.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: JRNY II XR INS XLPE MED 3-4 LT 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11391068
• Report Number: 1020279-2021-01678
• Device Sequence Number: 1283673
• Product Code: JWH
• UDI-Device Identifier: 00885556612866
• UDI-Public: 00885556612866
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: HK
• PMA/510(K) Number: K152726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/05/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/26/2026
• Device Model Number: 74023743
• Device Catalogue Number: 74023743
• Device Lot Number: 16FM20596
• Initial Date Received by Manufacturer: 02/05/2021
• Supplement Date Received by Manufacturer: 02/28/2021; 07/02/2021
• Initial Report FDA Received Date: 02/28/2021
• Supplement Report FDA Received Date: 03/30/2021; 07/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention