MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 HEAD DISTRACTOR; SHOULDER INSTRUMENT - HEAD DISTRACTOR

Catalog Number	620101171
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4) depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that the impactor handle and head distractor became fused together during surgery and could not be separated.
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 hat 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: d9.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: according to the information provided: "it was reported that parts 620101171 and 620101141 were put together during surgery.They are now fused together and cannot be separated ship replacements".The product was returned to depuy synthes for evaluation.Visual inspection revealed the head distractor and impactor handle assembled together.Device had signs of usage on its overall surface and no other cosmetic anomaly was identified on it.A dimensional inspection was not performed since it was not applicable to the complaint condition.Functional test performed revealed the devices could not be separated/disengaged from one another, impeding to observed the devices connector surfaces for damage.Potential cause can be traced to a possible internal damage on the connector area that led the devices to fail; damage that could have been caused by over torquing, off-axis assembly, excessive force applied during trialing or by impacting the impactor handle before the head distractor was fully seated.Properly handling and attention to the approved use of the device diminishes the risk of failure.Please see the inhance¿ shoulder system ¿ surgical technique (page 21 and 28) for the assembly considerations during the stemless and/or stemmed revision applied during procedure.The overall complaint was confirmed as the observed condition of the head distractor would have contributed to the complained device 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: 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.

• Brand Name: HEAD DISTRACTOR
• Common Device Name: SHOULDER INSTRUMENT - HEAD DISTRACTOR
• 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: 23897771
• Report Number: 1818910-2025-22591
• Device Sequence Number: 5128583
• Product Code: LXH
• UDI-Device Identifier: 10603295539643
• UDI-Public: (01)10603295539643(10)318645
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/26/2025

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: 620101171
• Device Lot Number: 318645
• 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: 12/15/2025
• Supplement Date Received by Manufacturer: 01/14/2026; 02/09/2026
• Initial Report FDA Received Date: 12/26/2025
• Supplement Report FDA Received Date: 01/15/2026; 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2022
• 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 Sex: Male