MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ATTUNE REV RP TRIAL SIZE 5; TIBIAL BASE PLATES

Model Number	2506-40-005
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Attune revision tibial tray not staying screwed into broach with extraction.Query internal screw issue in tibial base plate tray.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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.
Additional Manufacturer Narrative
Product complaint #(b)(4).Investigation summary: 5 attune revision tibial tray not staying screwed into broach with extraction.Query internal screw issue in tibial base plate tray.Nil adverse effects to patient during procedure due to this issue.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device from attachment "a-9415084 (b)(4) additional information".Visual analysis of the photo revealed the front view of the attune rev rp trial size 5 covered with what appears to be blood residues.However, functionality and device interaction issues cannot be assessed through a photo investigation.Additionally, base on the quality of the photo no defects that could have contributed to the reported unable to assemble allegation were observed.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was unconfirmed as the observed condition of the attune rev rp trial size 5 would not 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 records evaluation (mre) was not performed as no lot number was not able to retrieve by the provided photo evidence.
Event or Problem Description
Additional information was received.And stated, that the screw doesn't stay into the broach.
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.

• Brand Name: ATTUNE REV RP TRIAL SIZE 5
• Common Device Name: TIBIAL BASE PLATES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• 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: 17229144
• Report Number: 1818910-2023-13435
• Device Sequence Number: 6969805
• Product Code: HWT
• UDI-Device Identifier: 10603295450795
• UDI-Public: 10603295450795
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 06/29/2023

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 Model Number: 2506-40-005
• Device Catalogue Number: 250640005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2023
• Supplement Date Received by Manufacturer: 06/29/2023; 09/13/2023
• Initial Report FDA Received Date: 06/29/2023
• Supplement Report FDA Received Date: 07/05/2023; 09/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Male