MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ATTUNE REVISION SYSTEM HANDLE; KNEE INSTRUMENTS : HANDLES

Catalog Number	254600100
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the system handle latch did not open all the way.It was still usable in the case.There was no surgical delay.
Additional Manufacturer Narrative
Product complaint # (b)(4).H6 component code: appropriate term/code not available (g07002) used to capture no findings available.Investigation summary: an analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product is received at a later date, the investigation will be updated as applicable.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint (b)(4) investigation summary it was reported that the system handle latch did not open all the way.It was still usable in the case.There was no surgical delay.The device associated with this report was returned to depuy synthes for evaluation.Visual analysis of the returned sample revealed that the attune revision system, exhibits signs of normal use.No cosmetic defects were observed on the surface of the device.The functional test revealed that the thump slide shows signs of stiffness, as it was difficult to slide downwards, causing the lock lever not to open as intended.The reported complaint condition was able to be replicated.As per the instruction for use ifu-0902-00-836 rev.G "non-sterile surgical instruments", it is important to carefully inspect instruments between uses to verify proper functioning.Additionally, lubricate moving parts with water soluble lubricant per the manufactures instructions.Lubricate after cleaning and prior to sterilization.However, base on the available information, it is unknown if the moving parts were lubricated prior to use, therefore the a potential cause for the reported complaint condition cannot be established.The overall complaint was confirmed as the observed condition of the attune revision system handle would have contributed to the complained issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
Additional Manufacturer Narrative
Product complaint (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information, which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained, that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: ATTUNE REVISION SYSTEM HANDLE
• Common Device Name: KNEE INSTRUMENTS : HANDLES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18226940
• Report Number: 1818910-2023-24201
• Device Sequence Number: 20216630
• Product Code: LXH
• UDI-Device Identifier: 10603295438731
• UDI-Public: 10603295438731
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/29/2023

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 Catalogue Number: 254600100
• Device Lot Number: AB5123456
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2023
• Supplement Date Received by Manufacturer: 12/12/2023; 12/26/2023
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 12/13/2023; 12/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Male