MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS CONST ISRT TRL S1-2 11MM RT; PROSTHESIS, KNEE, PATELLOFEMTIB, SEMI-CONSTRAIND, CEMENTD, POLY/METAL/POLY

Model Number	74034213
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint reference: case (b)(4).
Event or Problem Description
It was reported that the devices were found cracked.This was found during set up / inspection.No surgery or patient involvement.
Additional Manufacturer Narrative
H3.H6: the device, used in treatment, was not returned for evaluation.Therefore, a product analysis could not be performed at this time and the reported event could not be confirmed.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.The device is a reusable instrument that can be exposed to numerous surgeries and cleaning cycles.As plastics are vulnerable and crack may have initiated during use and possible causes could be due to the heating and cooling associated with autoclaving or prolonged use.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.Without the return of the actual product involved, our investigation could not proceed.Should the device or 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 II BCS CONST ISRT TRL S1-2 11MM RT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMTIB, SEMI-CONSTRAIND, CEMENTD, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11045763
• Report Number: 1020279-2020-07621
• Device Sequence Number: 19091283
• Product Code: JWH
• UDI-Device Identifier: 00885556002797
• UDI-Public: 00885556002797
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K140555
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2021

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
• Operator of Device: Health Professional
• Device Model Number: 74034213
• Device Catalogue Number: 74034213
• Device Lot Number: 18BCR0003
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/24/2020
• Supplement Date Received by Manufacturer: 05/15/2021
• Initial Report FDA Received Date: 12/21/2020
• Supplement Report FDA Received Date: 05/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1