MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE POS FEM AUG SZ 5 8MM; KNEE FEMORAL ACCESSORY

Catalog Number	154905002
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the femoral accessory is not fixed with tibia plate.Was surgery delayed due to the reported event? --> unknown,.
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).Investigation summary according to the information received, ¿it's not fixed with tibia plate¿.The product was not returned to depuy synthes, however photos were provided for review.See attachment (processed-b8f67082-bc90-41d5-b696-eefedf73ce67.Jpeg).The photo investigation revealed that attune pos fem aug sz 5 8mm appears to have nothing indicative of a device nonconformance.The investigation could not draw any conclusions about the reported event due to the insufficient evidence provided.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was unconfirmed as the photographs attached are insufficient to draw a conclusion about the reported event.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 = > a manufacturing record evaluation was performed for the finished device attune pos fem aug sz 5 8mm product code: 154905002 lot number: m39g59 and no non-conformances or manufacturing irregularities were identified.
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 that 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.H11 additional narrative: added: d9.If information that was not available for the initial report is obtained, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: it's not fixed with tibia plate.The product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found nothing indicative of a device nonconformance that would have contributed to the reported allegation.A functional test was not performed since it was not applicable to the complaint condition.A dimensional inspection was performed for the attune pos fem aug sz 5 8mm and met specifications.A manufacturing record evaluation was performed for the finished device attune pos fem aug sz 5 8mm product code: 154905002 lot number: m39g59 and no non-conformances or manufacturing irregularities were identified.The overall complaint was not confirmed as the observed condition of the attune pos fem aug sz 5 8mm would have not 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 j&j medtech orthopaedics 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.Drawing/specifications reviewed: dwg-1154901502 rev d current and manufactured.Dimensional inspection: specified dimensions: aug length ø = 22.20 +/- 0.25mm.Aug width ø = 8.00+/- 0.25 mm.Straight tabs length ø = 5.00 +/- 0.13 mm.Tab to tab length ø = 15.80 +/- 0.25 mm.Measured dimensions: aug length ø = 22.18 mm (complies).Aug width ø = 8.03 mm (complies).Straight tabs length ø = 5.01mm (complies).Tab to tab length ø = 15.76 mm (complies).Device used ¿ digimatic caliper cd78621.Device history lot: a manufacturing record evaluation was performed for the finished device attune pos fem aug sz 5 8mm product code: 154905002 lot number: m39g59 and no non-conformances or manufacturing irregularities were identified.Device history review: a manufacturing record evaluation was performed for the finished device attune pos fem aug sz 5 8mm product code: 154905002 lot number: m39g59 and no non-conformances or manufacturing irregularities were identified.H11 additional narrative: corrected: h3.

• Brand Name: ATTUNE POS FEM AUG SZ 5 8MM
• Common Device Name: KNEE FEMORAL ACCESSORY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18873666
• Report Number: 1818910-2024-05498
• Device Sequence Number: 19572708
• Product Code: JWH
• UDI-Device Identifier: 10603295383062
• UDI-Public: 10603295383062
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P830055
• 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): 03/11/2024

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: 154905002
• Device Lot Number: M39G59
• 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: 03/05/2024
• Supplement Date Received by Manufacturer: 05/28/2024; 07/02/2025; 08/11/2025
• Initial Report FDA Received Date: 03/11/2024
• Supplement Report FDA Received Date: 05/29/2024; 07/03/2025; 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2023
• 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