MAUDE Adverse Event Report: DEPUY IRELAND ATUN REV FEM SLV TAPR SEP BASE; EXTRACTION INSTRUMENTS

Catalog Number	254600440
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2024
Type of Reportable Event	Malfunction
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 the information is unknown, not available or does not apply, the section/field of the form is left blank.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that during a knee surgery on (b)(6) 2024, the threads on the assembly sleeve separator was damaged and would not thread into the sleeve.The push rod was also bent.The surgery was not delayed due to these issues.
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: it was reported that the threads on the assembly sleeve separator are damaged and will not thread into the sleeve.The push rod is also bent.Both parts are needing replaced.The surgery was not delayed due to these issues.The product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found the threads at the end were severely stripped.The observed condition of the device is consistent with a component failure that was caused by exposure to unintended forces like overtightening the device while assembling; or by assembling the device in a misaligned position.Properly handling and attention to the approved use of the device diminishes the risk of failure.A functional test was not conducted due to the mating device not being returned for evaluation, however, due to the observed condition of the device, it is not unreasonable to conclude the device would present assembly issues.The allegation of unable to assemble can be confirmed.A dimensional inspection was not conducted due to not being applicable to the complaint condition the overall complaint was confirmed as the observed condition of the atun rev fem slv tapr sep base would have contributed to the complained device issue.Based on the investigation findings, the potential cause is traced to unintended use, and 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.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 records evaluation (mre) was not performed.

• Brand Name: ATUN REV FEM SLV TAPR SEP BASE
• Common Device Name: EXTRACTION INSTRUMENTS
• Manufacturer (Section D): DEPUY IRELAND; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 21079809
• Report Number: 1818910-2025-00236
• Device Sequence Number: 18267148
• Product Code: HWB
• UDI-Device Identifier: 10603295440482
• UDI-Public: (01)10603295440482(10)SO2053838
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• 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: 254600440
• Device Lot Number: SO2053838
• 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: 12/16/2024
• Supplement Date Received by Manufacturer: 01/08/2025; 01/20/2025
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 01/10/2025; 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2021
• 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 Age: 60 YR
• Patient Sex: Male