MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 LOCKING SCREW 35; SHOULDER IMPLANT - LOCKING SCREW

Catalog Number	550310035
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/04/2025
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.H11 additional manufacturer narrative: 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 during a total shoulder replacement procedure it was observe that the locking screw broke during insertion.It was reported that when the surgeon was inserting the device into somewhat sclerotic bone in the glenoid, screw head sheared off.It was reported that the surgeon attempted to remove the shaft of the broken screw but was unsuccessful in doing so.It was reported that there was a 30-minute delay in the procedure due to the event.It was reported that the procedure was successfully completed.There were no reported consequences to the patient.No additional information could be provided.
Additional Manufacturer Narrative
Product complaint #(b)(4).Investigation summary: an analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Based on the information available, there is no indication that a design or manufacturing issue has caused the reported complaint condition; therefore it has been determined that no corrective and preventive action is required at this time.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product is received at a later date, the investigation will be updated as applicable.

• Brand Name: LOCKING SCREW 35
• Common Device Name: SHOULDER IMPLANT - LOCKING SCREW
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; 9083863534
• MDR Report Key: 23829448
• Report Number: 1818910-2025-22076
• Device Sequence Number: 9030587
• Product Code: HSD
• UDI-Device Identifier: 10603295546603
• UDI-Public: (01)10603295546603(10)204220
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K212737
• 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,User Facility,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: 550310035
• Device Lot Number: 204220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/05/2025
• Supplement Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 01/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown