MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*HANDLE-T,HUDSON; HIP INSTRUMENTS : HANDLES

Catalog Number	530360
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient underwent a tks surgery with the products in question.When setting up the products before the surgery, it was discovered that the t-handle and punch were not compatible.When used during the surgery, they became stuck and could not be removed.There was no problem during surgery, but the user complained.The surgery was completed successfully with no surgical delay.No further information is available.
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.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.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: it was reported that on (b)(6) 2025, the patient underwent a tks surgery with the products in question.When setting up the products before the surgery, it was discovered that the t-handle and punch were not compatible.When used during the surgery, they became stuck and could not be removed.There was no problem during surgery, but the nurse complained.The surgery was completed successfully with no surgical delay.No further information is available.The product was returned to depuy synthes for evaluation.Visual analysis found that the s-rom*handle-t,hudson was returned seized with the im initiator sized.The assessment was performed and was able to replicate the reported allegation, the devices were unable to disengage after multiple attempts with excessive forces applied.The potential cause of the two devices becoming stuck/unable to disassemble is an incompatibility between them.The im initiator sized (200180501) was designed for use with the excel t-handle (200142000).In older revisions of the s-rom handle-t, hudson (530360), the connector is not compatible with the im initiator sized (200180501).Mating these incompatible components can result in improper engagement of the connector and mechanical interference, which may cause the devices to jam.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-rom*handle-t,hudson would have contributed to the complained 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: a device history record (dhr) review or manufacturing records evaluation (mre) was not possible because the date code ak0606 provided is not a valid finished goods lot number.Corrected: h3.

• 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: 23372423
• Report Number: 1818910-2025-18153
• Device Sequence Number: 12981646
• Product Code: LXH
• UDI-Device Identifier: 10603295171546
• UDI-Public: (01)10603295171546(10)AK0606
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: 530360
• Device Lot Number: AK0606
• 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: 10/03/2025
• Supplement Date Received by Manufacturer: 10/30/2025; 12/29/2025
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 10/31/2025; 12/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2006
• 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