MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II UNI RESECT PREP TRL RM/LL SZ 4; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	74035834
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the sliding mechanism fell out of jrny ii uni resect prep trl rm/ll sz 4.It is unknown when the incident occurred.It is also unknown if there was any case involved.
Additional Manufacturer Narrative
H3, h6: the associated device, intended for use, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device is missing a dial pin spike rail rendering the device inoperable.A review of complaint history did not reveal additional complaints for the listed batch.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the product failed to meet any product 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 probable causes of 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.
Additional Manufacturer Narrative
Section h3, h6: the associated device, intended for use, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device is missing a dial pin spike rail rendering the device inoperable.A review of complaint history did not reveal additional complaints for the listed batch.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.Based on the quality investigation, the root cause of the reported event was a failure to follow in meeting the design specification as called out on the print for the hole size and press fit condition, also, design robustness for manufacturability.At this time, we have evidence to confirm that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, several improvements were implemented related to product specifications, process monitoring and assembly process.In addition, this event was addressed through a market removal of the product.Containment and remedial actions were performed for the impacted finished product.Should additional information be received, the complaint will be reopened.We will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.B5: describe event or problem, h6: health effect - clinical code, investigation findings and investigation conclusions.
Event or Problem Description
It was reported that the sliding mechanism fell out of jrny ii uni resect prep trl rm/ll sz 4.It is unknown when the defective device was found.It is also unknown if there was any case involved.

• Brand Name: JRNY II UNI RESECT PREP TRL RM/LL SZ 4
• 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
• MDR Report Key: 10879716
• Report Number: 1020279-2020-06612
• Device Sequence Number: 19915796
• Product Code: HSX
• UDI-Device Identifier: 00885556690451
• UDI-Public: 00885556690451
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K190085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/28/2022

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: 74035834
• Device Catalogue Number: 74035834
• Device Lot Number: 20BM21110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2021
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 10/28/2020
• Supplement Date Received by Manufacturer: 04/28/2021; 09/27/2022
• Initial Report FDA Received Date: 11/20/2020
• Supplement Report FDA Received Date: 05/10/2021; 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2133-2020
• Patient Sequence Number: 1
• Patient Sex: Unknown