MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FB INSRT SZ 6 6MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Catalog Number	151620606
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a black hair firmly sticking to the insert inside the sterile package.Seen upon opening the inner sterile package.There was no patient harm.
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.
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 hat 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.H11 additional narrative: 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 = > hcp is reporting a black hair firmly sticking to the insert inside the sterile package.See photo.Seen upon opening the inner sterile package.Photos were provided for review.See attachment "photos".The photo investigation revealed that the packing of the attune cr fb insrt sz 6 6mm was opened and manipulated due to presents blood remnants.Additionally, the insert shows what appears to be a small hair adhered to its surface.With the available information, and due to the device was manipulated no further evaluation was able to be performed.Consequently, there is no indication of any manufacturing error that could have contributed to the reported "foreign matter - inside sterile packaging" issue.Without concrete evidence or further information, it is not possible to determine a root cause.A manufacturing record evaluation was performed for the finished device product description: attune cr fb insrt sz 6 6mm, product code: 151620606 lot number: md4193, and no non-conformances nor manufacturing irregularities were identified.The overall complaint was confirmed as the condition of the attune cr fb insrt sz 6 6mm can be seen from the photographs provided and would contribute to the reported foreign matter inside the sterile packaging.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 = > 1) quantity manufactured: (b)(4) 2) date of manufacture: 11/19/2025 3) any anomalies or deviations identified in dhr: none 4) expiry date: 10/31/2030 5) ifu reference: (b)(4) device history review = > a manufacturing record evaluation was performed for the finished device product description: attune cr fb insrt sz 6 6mm, product code: 151620606 lot number: md4193, and no non-conformances nor manufacturing irregularities were identified.Added: d4 (expiration date), h4 corrected: d4 (primary udi).

• Brand Name: ATTUNE CR FB INSRT SZ 6 6MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 24511841
• Report Number: 1818910-2026-04086
• Device Sequence Number: 13376160
• Product Code: JWH
• UDI-Device Identifier: 10603295045779
• UDI-Public: (01)10603295045779(17)301031(10)MD4193
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K101433
• 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,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: 151620606
• Device Lot Number: MD4193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2026
• Supplement Date Received by Manufacturer: 03/04/2026; 04/15/2026; 05/07/2026; 05/14/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 03/06/2026; 04/16/2026; 05/11/2026; 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2025
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown