MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE REV T AUGTRL 5MM SZ5LL; FEMORAL TRIALS

Catalog Number	252305201
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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.
Event or Problem Description
It was reported that instruments were rusted.
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary according to the information received, ¿customer reports not reprocessing orthokit due to containing rusty components¿.The product and photos of the reported event returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device and attachments "photo_1, photo_2 and photo_3" visual analysis of the returned sample revealed that attune rev t augtrl 5mm sz5ll (lot.So2055532) presents several brown-orange stains throughout the entire surface, mostly located on the engraving and the internal lateral side.The scanning electron microscope (sem) and energy dispersive spectroscopy (eds) tests performed on one of the returned instruments (recorded on the related pc-(b)(4) revealed that oxygen is actively participates in the brown-orange staining, confirming the presence of corrosion.The documentation for the passivation pms of the attune rev t augtrl 5mm sz5ll (lot.So2055532) were reviewed and no non-conformances / deviations were identified during manufacturing.Additionally, no deviations in the passivation process during the time frame in which the product was manufactured were identify.There is no indication that a design or manufacturing issue has caused or contributed to the reported event.Corrosion is not an expected failure if it is used as intended and the parameters within the instructions for use (ifu) are followed for cleaning, decontamination and sterilization.The device had experienced approximately 3.1 years of use, and the number of procedures (cycles) it had gone through its life in the field is unknown.Although the observed condition of the instrument cannot be attributed to design or manufacturing, with the information available, a definitive root cause cannot be established at this time due to there being multiple factors that may influence.A manufacturing record evaluation was performed for the finished device [252305201 / so2055532] number, and no non-conformances / manufacturing irregularities related to the malfunction were identified during manufacturing.The overall complaint was confirmed as the observed condition of the attune rev t augtrl 5mm sz5ll would contribute to the complained device 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 a manufacturing record evaluation was performed for the finished device [252305201 / so2055532] number, and no non-conformances / manufacturing irregularities related to the malfunction were identified during manufacturing.Device history review a manufacturing record evaluation was performed for the finished device [252305201 / so2055532] number, and no non-conformances / manufacturing irregularities related to the malfunction were identified during manufacturing.

• Brand Name: ATTUNE REV T AUGTRL 5MM SZ5LL
• Common Device Name: FEMORAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• 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: 18992233
• Report Number: 1818910-2024-06989
• Device Sequence Number: 2932190
• Product Code: LXH
• UDI-Device Identifier: 10603295437253
• UDI-Public: (01)10603295437253(10)SO2055532
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/28/2024

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: 252305201
• Device Lot Number: SO2055532
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/25/2024
• Supplement Date Received by Manufacturer: 04/03/2024; 04/29/2024; 09/11/2024
• Initial Report FDA Received Date: 03/28/2024
• Supplement Report FDA Received Date: 04/04/2024; 05/06/2024; 09/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2021
• 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 Sex: Unknown