MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE REV TIB SLV SEP TIB SLV; TIBIAL SLEEVE SEPARATOR

Catalog Number	254600453
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/05/2024
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.Additional narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that during a procedure on (b)(6) 2024, the two instruments attune rev tib sleeve base attachment and attune rev tib sleeve separator became stuck with old implants and were unable to be removed despite multiple efforts.Old implants stuck with items from an infected case so would not be returned.There was no surgical delay and no patient consequence.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary according to the information received, "two instruments became with old implant whilst using and unable to remove despite multiple efforts.Old implants stuck with items from an infected case so not appropriate for return." the product was not returned to j&j medtech orthopaedics; however, photos were provided for review.See attachment ((b)(4) pc request).The photo investigation revealed the atune rev tibslv sep bas attach assembled with its mating components.However, with the information provided, and as functionality issues cannot be evaluated through a photo investigation, no other observations pertaining to the nature of the reported event could be identified.As the device was not returned, and as-received condition could not be assessed, a dimensional inspection and document/specification review were not completed.The device lot number is unknown, therefore a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.The overall complaint was not confirmed as the observed condition of the attune rev tib slv sep tib slv 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 complaint condition.As part of 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.Device history lot the device lot number is unknown, therefore a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.H11 additional narrative: added: g1 (manufacturing site name).
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.H11 additional narrative: added: b5, d4 (lot).Corrected: d4 (primary udi number).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Additional information was received and confirmed that the original implants were infected.The surgeon revised the femoral side.

• Brand Name: ATTUNE REV TIB SLV SEP TIB SLV
• Common Device Name: TIBIAL SLEEVE SEPARATOR
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 20969235
• Report Number: 1818910-2024-25671
• Device Sequence Number: 3954635
• Product Code: HWB
• UDI-Device Identifier: 10603295440277
• UDI-Public: (01)10603295440277(10)AB5042829
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• 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

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: 254600453
• Device Lot Number: AB5042829
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/05/2024
• Supplement Date Received by Manufacturer: 12/23/2024; 01/02/2025
• Initial Report FDA Received Date: 12/18/2024
• Supplement Report FDA Received Date: 12/24/2024; 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown