MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 ATUNE CR RT MS INS SZ 6 5; KNEE IMPLANT - TIBIAL INSERT

Catalog Number	152020605
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2025
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 medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that surgeon went to impact the 6x5mm ms poly and it wasn¿t properly seating and locking into the tray.Surgeon removed the 5mm insert, tried a 6x6mm ms poly and it did the same thing.Not properly seating and locking into the tray.Surgeon had us open a 6x7mm ms poly and that one seated properly.It added about 5 mins to total case time.Doi: unknown.Dor: (b)(6) 2025.Affected side: right knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information provided: "it was reported that surgeon went to impact the 6x5mm ms poly and it wasn¿t properly seating and locking into the tray.Surgeon removed the 5mm insert, tried a 6x6mm ms poly and it did the same thing.Not properly seating and locking into the tray.Surgeon had us open a 6x7mm ms poly and that one seated properly.Added about 5 mins to total case time".The product was returned to depuy synthes for evaluation.Visual inspection of the returned device found signs of implantation attempts on its overall surface, including scratches and delaminated portions.Additionally, excess of material was identified on the central part of the device locking area.Device was sent for further investigation to the manufacture site.Per customer provided information the dhr for the alleged defective medical devices was reviewed and found complete without any irregularities.The alleged defective medical devices were produced at the manufacturer site, ireland facility in a lot of (b)(4) pieces.The parts were returned to manufacturer for review, and while the exact cause the deformation could not be determined, it can be stated that it was not due to an error at the manufacturer site.The product is manufactured through verified and controlled cnc programs.All product from this lot was 100% visually inspected and dimensionally inspected as specification prior to shipment to the customer per standard procedure for this product and no defects were identified.A review of the quality management system was carried out and there were no instances of similar defects recorded.It can be stated that the alleged non-conformance was not due to an error at the manufacturer.Based on the results of this investigation, no manufacturing related issues were identified that could have resulted in the alleged defective medical devices.Therefore, no further actions are required by the manufacturer, and this complaint investigation is considered complete and closed.However, consideration must be taken to all other potential influences such as surgical process; improper handling/care of the device; excessive force applied while assembling the device; a misaligned assembly between the device and its mating component; or by other environmental/external factors that the device could have been exposed to (outside of the depuy synthes control).Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.A functional test was unable to be performed due to the post-manufacturing damage.However, given the damage observed on the central part of the device locking area, it is reasonable to confirm that the device could not be assembled as intended.The overall complaint was confirmed as the observed condition of the atune cr rt ms ins sz 6 5 would have contributed 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 m95w66 lot number, and no non-conformances nor manufacturing irregularities were identified.H11 additional narrative: added: d10 (concomitant) corrected: h3.

• Brand Name: ATUNE CR RT MS INS SZ 6 5
• Common Device Name: KNEE IMPLANT - TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthpaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 22965561
• Report Number: 1818910-2025-15224
• Device Sequence Number: 21097915
• Product Code: JWH
• UDI-Device Identifier: 10603295542568
• UDI-Public: (01)10603295542568(17)330630(10)M95W66
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K211609
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup

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: 152020605
• Device Lot Number: M95W66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/18/2025
• Supplement Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 09/04/2025
• Supplement Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATUNE CR RT MS INS SZ 6 6
• Patient Age: 74 YR
• Patient Sex: Male