MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S/C TRIAL HANDLE; HIP INSTRUMENTS : HANDLES

Catalog Number	205512000
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the modular endo trials handles have 4 bearings on the end of the handle and the inside has bio burden in them that facility could not get out.They washed them and put them in sonic several times and still bio burden leaked out.
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.H11 additional manufacturer narrative: 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).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information that 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 recon described in this report.H11 additional narrative: added: d9, h4.If information that was not available for the initial report is obtained, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information received, "the modular endo trials handles have 4 bearings on the end of handle and the inside has bio burden in them that facility can not get out.They washed them and put them in sonic several times and still bio burden leaked out." the product was returned to depuy synthes for evaluation.Visual inspection found some debris attached to the ball plungers of the s/c trial handle.Additionally, signs of heavy usage was found on the overall device surface.Per ifu-0902-00-721, care should be taken to remove any debris, tissue, or bone fragments that may collect on the instrument.Instruments with cannulas, moving parts, or spring mechanisms require additional cleaning steps to ensure proper removal of all trapped debris.In addition to other important steps to follow, the ifu instructs the use of a soft bristle brush to remove all traces of blood and debris, paying close attention to threads, crevices, seams, and any hard-to-reach areas of the device features.If the instrument has sliding mechanisms or hinged joints, actuate the area to free any trapped blood and debris.A functional test was not performed since it was not applicable to the complaint condition.A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the s/c trial handle would have contributed to the complained issue.Based on the investigation findings, the potential cause is traced to maintenance, 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 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: d4 (lot, primary udi number), h3.

• Brand Name: S/C TRIAL HANDLE
• Common Device Name: HIP INSTRUMENTS : HANDLES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 23490831
• Report Number: 1818910-2025-19320
• Device Sequence Number: 14626446
• Product Code: LXH
• UDI-Device Identifier: 10603295084471
• UDI-Public: (01)10603295084471(10)PG330702
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,User Facility,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: 205512000
• Device Lot Number: PG330702
• 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: 10/20/2025
• Supplement Date Received by Manufacturer: 11/13/2025; 11/24/2025
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 11/17/2025; 11/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2022
• 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: 78 YR
• Patient Sex: Female