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

Device Problem Connection Problem (2900)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/28/2020

Event Type  malfunction  

Event 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.

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.

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 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
• Type of Device: 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
• MDR Text Key: 217630227
• Report Number: 1020279-2020-06612
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00885556690451
• UDI-Public: 00885556690451
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190085
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 09/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-2133-2020
• Patient Sequence Number: 1