MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 EMPHASYS; HIP INSTRUMENT - IMPACTOR

Catalog Number	481436050
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a total hip replacement surgical procedure two things happened in this case.While the surgeon was impacting the poly into the acetabular cup the impactor tip broke.No delay in case and no issues to the patient.All pieces were accounted for.The second thing that happened was there was a sharp edge on the broach handle that tore the surgeons glove.No issues with either the surgeon or the patient.
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.

• Brand Name: EMPHASYS
• Common Device Name: HIP INSTRUMENT - IMPACTOR
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 25670520
• Report Number: 1818910-2026-11225
• Device Sequence Number: 12171967
• Product Code: HWA
• UDI-Device Identifier: 10603295509684
• UDI-Public: (01)10603295509684(10)AZ483814
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: 481436050
• Device Lot Number: AZ483814
• 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: 06/15/2026
• Supplement Date Received by Manufacturer: 06/30/2026; 07/14/2026
• Initial Report FDA Received Date: 06/30/2026
• Supplement Report FDA Received Date: 07/01/2026; 07/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2024
• 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 Age: 63 YR
• Patient Sex: Male