MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 EMSYS LNR IMP TIP ADPT; HIP INSTRUMENT - IMPACTOR

Catalog Number	481400050
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Patient underwent hip surgery on (b)(6), 2025.Using emphasys instruments, the liner impactor adaptor cross threaded as it was attached to the impactor.The result was that the adaptor became very tight on the impactor handle.Additionally, the liner impactor head size 36 became very tight on the adaptor.The two had to be separated using grips and this process damaged the adaptor shaft.Procedure was completed successfully with a three minute delay.There was no patient consequence.
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.Additional narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.
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: added: d4 (lot), d9, h4.Corrected: d4 (primary udi #).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: using emphasys instruments the liner impactor adaptor cross threaded as it was attached to the impactor.The result was that the adaptor became very tight on the impactor handle.Additionally, the liner impactor head size 36 became very tight on the adaptor.As a result, the two had to be separated using grips and this process damaged the adaptor shaft.The product was returned to depuy synthes for evaluation.Visual inspection reveled that the emsys lnr imp tip adpt was returned disassembled.Additionally it was noted that its internal threads are cross-threaded.No other anomalies were noted.Potential cause can be traced to a random component failure that may have been caused by exposure to unintended forces, such as overtightening, assembling the device in a misaligned position or by impacting the device before it was fully threaded/seated.Properly handling and¿attention to the approved use of the device diminishes the risk of failure.Functional test was unable to be performed since the mating device was not returned for evaluation, however the observed cross-threaded condition of the emsys lnr imp tip adpt can lead to the inability or difficulty to disassemble the mating component as intended, substantiating the reported allegation.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 adpt would have contributed to the complained issue.Based on the investigation findings, the potential cause is traced to unintended use error, and it has been determined that no corrective and/or preventative action is required.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.Corrected: h3.

• Brand Name: EMSYS LNR IMP TIP ADPT
• 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: 23137262
• Report Number: 1818910-2025-16455
• Device Sequence Number: 12973543
• Product Code: HWA
• UDI-Device Identifier: 10603295522560
• UDI-Public: (01)10603295522560(10)AZ524892
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: 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: 481400050
• Device Lot Number: AZ524892
• 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: 09/08/2025
• Supplement Date Received by Manufacturer: 11/18/2025; 11/24/2025
• Initial Report FDA Received Date: 09/24/2025
• Supplement Report FDA Received Date: 11/20/2025; 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2025
• 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