MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II UNI RESECT PREP TRL RM/LL SZ 3; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 74035833

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 the jrny ii uni resect prep trl rm/ll sz 3.It is unknown when the incident occurred.It is also unknown if there was any case involved.

Manufacturer Narrative

The devices, intended for use in treatment, were returned for evaluation.A visual inspection of the returned device confirmed the stated failure mode.It appears that the sliding mechanism is missing rendering the device inoperative.The missing pieces were not returned.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of the complaint history on the listed part revealed no prior complaints for the listed failure mode with the same batch number.These devices are reusable instruments that can be exposed to numerous surgeries; damage from repeated use can occur.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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

Manufacturer Narrative

The device, intended for use in treatment, was returned for evaluation.A visual inspection of the returned device confirmed the stated failure mode.It appears that the sliding mechanism is missing rendering the device inoperative.The missing pieces were not returned.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of the complaint history on the listed part revealed no prior complaints for the listed failure mode with the same batch number.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.The device failed to meet specifications.As a result of the investigation, several improvements were implemented related to product specifications, process monitoring and assembly process.In addition, 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.

• Brand Name: JRNY II UNI RESECT PREP TRL RM/LL SZ 3
• 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: 10879672
• MDR Text Key: 217647749
• Report Number: 1020279-2020-06609
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00885556690444
• UDI-Public: 00885556690444
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/09/2021

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: 74035833
• Device Catalogue Number: 74035833
• Device Lot Number: 19JM18540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2019
• 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-2132-2020
• Patient Sequence Number: 1