MAUDE Adverse Event Report: DEPUY IRELAND STEM EXTRACTORDLE; EXTRACTION INSTRUMENT

Catalog Number	17601A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2025
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 the device threads seemed to have cross threaded and were not functioning correctly.There was no patient or procedure involvement.
Additional Manufacturer Narrative
Product complaint # (b)(4) investigation summary item was reported for unknown reason.It did not happen in surgery.Additional information received; i noticed this at the office prior to sending out to a surgery.The threads seem to have cross threaded and were not functioning correctly.The product was returned to depuy synthes for evaluation.Visual analysis revealed that the stem extractordle exhibits an overall appearance of constant usage.Additionally, the threads of the bolt are cross-threaded.Functional testing revealed that both the threaded extractor bolt and nut were seized.Despite multiple attempts and the application of excessive force, the nut could not be rotated as intended due to bolt's threads condition.A dimensional inspection was not performed since it was not applicable to the complaint condition.The evaluation of the returned device, as well as previous failure analysis performed of related complaints (b)(4), found the failure of the mechanism was attributed to excessive loading applied to the stem extractor nut, which exceeded the local shear strength of the material.This condition resulted in thread deformation, fracture, and galling events.Consequently, these failures caused the seizing of the stem extractor nut and bolt, which could cause fracture of the stem extractor bolt during attempts to untighten the seized assembly.The overall complaint was confirmed as the observed condition of the stem extractordle would have 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 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 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.H11 additional narrative: corrected: h3.

• Brand Name: STEM EXTRACTORDLE
• Common Device Name: EXTRACTION INSTRUMENT
• Manufacturer (Section D): DEPUY IRELAND; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 23616447
• Report Number: 1818910-2025-20514
• Device Sequence Number: 9988409
• Product Code: LXH
• UDI-Device Identifier: 00197169176018
• UDI-Public: (01)00197169176018(10)PG351900
• Combination Product (Y/N): N
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,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: 17601A
• Device Lot Number: PG351900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/22/2025
• Supplement Date Received by Manufacturer: 11/27/2025
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 12/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2024
• 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