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

Catalog Number	481440050
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that the impactor tip broke into 2 pieces when surgeon was implanting the liner.Both pieces were immediately retrieved and there was no surgical delay.
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.H11 additional 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).Investigation summary: it was reported that the impactor tip broke into 2 pieces when surgeon was implanting the liner.Both pieces were immediately retrieved and there was no surgical delay the product was returned to depuy synthes for evaluation.Visual inspection of the returned device found that the emsys lnr imp tip was broken around the threaded section.Broken fragments were returned for evaluation.With available information a definitive potential cause can not be established at this moment.This issue is being investigated through depuy synthes quality system.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 emsys lnr imp tip 40 would have contributed to a device issue.Based on the information currently available, a product issue was identified during the investigation of the sample received.This product issue will be addressed through depuy synthes quality system.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.Corrected: h3.

• 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: 24866006
• Report Number: 1818910-2026-06777
• Device Sequence Number: 10488963
• Product Code: HWA
• UDI-Device Identifier: 10603295510208
• UDI-Public: (01)10603295510208(10)AZ642696
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/13/2026

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: 481440050
• Device Lot Number: AZ642696
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/26/2026
• Supplement Date Received by Manufacturer: 04/15/2026; 04/27/2026
• Initial Report FDA Received Date: 04/13/2026
• Supplement Report FDA Received Date: 04/16/2026; 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2022
• 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: 73 YR
• Patient Sex: Female