MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FB TIB BASE SZ 6 CEM; KNEE TIBIAL TRAY

Catalog Number	150670006
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	07/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Intraoperatively when outer sterile package was removed, a hair was on the cover of the inner sterile package.There was no surgical delay and no adverse patient consequences.Another product was available and used without issues.
Additional Manufacturer Narrative
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: added: d9.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: intraoperatively when outer sterile package was removed a hair was on the cover of the inner sterile package.The product was returned to depuy synthes for evaluation.The complaint unit was forwarded to the manufacturing site depuy cork.Visual analysis of the returned attune fb tib base sz 6 cem found no evidence of a foreign matter.No anomalies were found.A manufacturing record evaluation was performed for the finished device product description: attune fb tib base sz 6 cem product code: 150670006 lot number: 4789936 and no non-conformances or manufacturing irregularities related to the complaint condition were identified.Based on the manufacturing investigation and with the available information and provided evidence, no further evaluation was able to be performed to determinate the source of the foreign matter.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 confirm the reported allegation.A functional test was not performed since it was not applicable to the complaint condition.A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was not confirmed as the observed condition of the attune fb tib base sz 6 cem would not 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 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: 5/15/2025.3) any anomalies or deviations identified in dhr: 1 non-conformance not related to the reported complaint condition.4) expiry date: 4/30/2035.5) ifu reference: ifu-0902-00-828.Device history review: a manufacturing record evaluation was performed for the finished device product description: attune fb tib base sz 6 cem product code: 150670006 lot number: 4789936 and no non-conformances or manufacturing irregularities related to the complaint condition were identified.Corrected: h3.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: intraoperatively when outer sterile package was removed a hair was on the cover of the inner sterile package.Photo was provided for review.(b)(4) photos.The photo investigation revealed what appears to be a hair above the tyvek pouch.With the available information and provided evidence, no further evaluation was able to be performed to determinate the source of the foreign matter.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 fb tib base sz 6 cem product code: 150670006 lot number: 4789936 and no non-conformances or manufacturing irregularities related to the complaint condition were identified.The overall complaint was confirmed as the condition of the attune fb tib base sz 6 cem can be seen from the photograph 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 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: quantity manufactured: (b)(4).2) date of manufacture: 5/15/2025.3) any anomalies or deviations identified in dhr: 1 non-conformance not related to the reported complaint condition.4) expiry date: 4/30/2035.5) ifu reference: ifu-0902-00-828.Device history review: a manufacturing record evaluation was performed for the finished device product description: attune fb tib base sz 6 cem product code: 150670006 lot number: 4789936 and no non-conformances or manufacturing irregularities related to the complaint condition were identified.

• Brand Name: ATTUNE FB TIB BASE SZ 6 CEM
• Common Device Name: KNEE TIBIAL TRAY
• 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: 22842297
• Report Number: 1818910-2025-14473
• Device Sequence Number: 17355741
• Product Code: JWH
• UDI-Device Identifier: 10603295492085
• UDI-Public: (01)10603295492085(17)350430(10)4789936
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K233982
• 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

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: 150670006
• Device Lot Number: 4789936
• 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: 08/05/2025
• Supplement Date Received by Manufacturer: 08/25/2025; 12/01/2025; 12/01/2025
• Initial Report FDA Received Date: 08/19/2025
• Supplement Report FDA Received Date: 08/26/2025; 12/02/2025; 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2025
• 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
• Patient Sex: Unknown