MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE REV TIBIAL PREP TOWER; DRILL GUIDES

Catalog Number	250620100
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
When preparing the tibia, the attune revision cemented conical reamer 250620103 got stuck in the attune revision tibial prep tower.It took a few extra minutes for the surgical team to complete the procedure.Upon inspection of the instruments after the operation you can see that the reamer is burred.The operation was successfully completed.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information received, ¿when preparing the tibia, the attune revision cemented conical reamer 250620103 got stuck in the attune revision tibial prep tower 250620100.It took a few extra minutes for the surgical team to complete the procedure.Upon inspection of the instruments after the operation you can see that the reamer is burred.The operation was successfully completed".The product was returned to depuy synthese for evaluation.The depuy synthese team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that attune rev tibial prep tower was received disassemble form its mating device, therefore the jammed allegation cannot be confirmed.However, several scratches and nicks were observed in the inner surface.Where the mating device assembles.Additionally, the functional test revealed that the returned attune rev tibial prep tower was not able to advance through the "fb" line of the attune rev tib cem conical rmr.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces such as off axis drilling under power and not properly align the reamer prior the insertion into the tower.The overall complaint was confirmed as the observed condition of the attune rev tibial prep tower would contribute to a 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 synthese 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 product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.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 synthese, or its employees that the report constitutes an admission that the product, depuy synthese, 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.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 synthese, or its employees that the report constitutes an admission that the product, depuy synthese, 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 TIBIAL PREP TOWER
• Common Device Name: DRILL GUIDES
• 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 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19074429
• Report Number: 1818910-2024-07917
• Device Sequence Number: 6900391
• Product Code: LXH
• UDI-Device Identifier: 10603295436034
• UDI-Public: 10603295436034
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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
• Report Date (Section B): 04/09/2024

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: 250620100
• Device Lot Number: NW263838
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/08/2024
• Initial Report FDA Received Date: 04/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2020
• 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