MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 HUMERAL HEAD TRIAL 42X16.5; SHOULDER INSTRUMENT - HEAD TRIAL

Catalog Number	620042165
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2025
Type of Reportable Event	Malfunction
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.Additional narrative: h3, h6: photo investigation summary: the photo investigation revealed that the humeral head trial 42x16.5 had one internal tab broken.The complaint can be confirmed as the reported crack condition may have led to the breakage.H3, h6: product investigation summary: the product was returned to depuy synthes for evaluation.Visual analysis of the returned device revealed that the humeral head trial 42x16.5 had one internal tab broken.Fragment was not returned for evaluation.The complaint can be confirmed as the reported crack condition may have led to the breakage.The observed condition of the device was consistent with a component failure that may have been caused by exposure to unintended forces while disassembling the offset taper adapter trial, per inhance¿ shoulder system anatomic surgical technique with hybrid glenoid addendum (103832905 rev b) page 18, section humeral head trial disassembly: to remove the humeral head trial, assemble the head distractor to the impactor handle and place between the resection and the humeral head.To remove the offset taper adapter trial from the humeral head trial, rotate the offset taper adapter trial counterclockwise until the ramps unlock it from the head.Once the offset taper adapter trial reaches the eject position, it will engage the ramp and come out of the humeral head trial.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 humeral head trial 42x16.5 would contribute 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.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 tab cracked/broken off humeral head trial for inhance.There was no patient or procedure involvement.

• Brand Name: HUMERAL HEAD TRIAL 42X16.5
• Common Device Name: SHOULDER INSTRUMENT - HEAD TRIAL
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthpaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 23693222
• Report Number: 1818910-2025-20962
• Device Sequence Number: 9124087
• Product Code: HWT
• UDI-Device Identifier: 10603295539186
• UDI-Public: (01)10603295539186(10)321070
• Combination Product (Y/N): N
• 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

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: 620042165
• Device Lot Number: 321070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2022
• 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: Unknown