MAUDE Adverse Event Report: DePuy Ireland - 3015516266 LOCKING SCREW 20; Shoulder Implant - Locking Screw

Catalog Number	550310020
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the screw head snapped off while implanting in the patient.The shaft of the screw was still in the patient.
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.

• Brand Name: LOCKING SCREW 20
• Common Device Name: Shoulder Implant - Locking Screw
• Manufacturer (Section D): DePuy Ireland - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; +1(908)386-3534
• MDR Report Key: 50735198
• Report Number: 1818910-2026-15628
• Device Sequence Number: 10633127
• Product Code: HSD
• UDI-Device Identifier: 10603295546573
• UDI-Public: (01)10603295546573(10)233599
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K212737
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• 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: 550310020
• Device Lot Number: 233599
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/24/2026
• Supplement Date Received by Manufacturer: 09/14/2026
• Initial Report FDA Received Date: 09/11/2026
• Supplement Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/18/2025
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Female