MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 HUMERAL HEAD TRIAL 44X15.25; SHOULDER INSTRUMENT - HEAD TRIAL

Catalog Number	620044152
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the trials have broken parts on the bottom, and the glenosphere tip was internally stripped.The event did not happened during a surgery.
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.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 received "it was reported that the trials have broken parts on bottom and the glenosphere tip internally stripped.The event did not happened during a surgery." the product was returned to j&j medtech orthopaedics for evaluation.Visual analysis of the returned device revealed that humeral head trial had broken the internal tabs.The broken fragments were not returned for evaluation.Per inhance¿ shoulder system anatomic surgical technique (103832905 rev b) page 18, the humeral head trials are offered with a modular offset taper adapter trial.To assemble the two components, orient the offset taper adapter trial so that the taper and laser line are facing up.Align the laser mark on the offset taper adapter trial with the c and laser line on the underside of the humeral head trial so that the flexible nub on the offset taper adapter trial sits with the notch on the underside of the humeral head trial marked c.Then apply pressure to snap the two components together.Humeral head trial disassembly, page: 21: 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.From the e=eject position, additional counterclockwise rotation of the offset taper adapter trial will push it up the ramp and out of the humeral head trial.The observed breakage of the device was consistent with a component failure that may have been caused by exposure to unintended forces during the assembling or disassembling process.The overall complaint was confirmed as the observed condition of the humeral head trial would have contributed to the complained device issue.Based on the investigation findings, the potential cause is traced to unintended user error.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics 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.H11 additional narrative: added: g1 (manufacturing site name).Corrected: h3.

• Brand Name: HUMERAL HEAD TRIAL 44X15.25
• Common Device Name: SHOULDER INSTRUMENT - HEAD TRIAL
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 22357525
• Report Number: 1818910-2025-10871
• Device Sequence Number: 8621239
• Product Code: HWT
• UDI-Device Identifier: 10603295539193
• UDI-Public: (01)10603295539193(10)319001
• 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,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: 620044152
• Device Lot Number: 319001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/10/2025
• Supplement Date Received by Manufacturer: 07/04/2025
• Initial Report FDA Received Date: 06/30/2025
• Supplement Report FDA Received Date: 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2022
• 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 Sex: Unknown