MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 CENTRAL SCREW 6.0X35; SHOULDER IMPLANT - SCREW

Catalog Number	550035600
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Foreign Body In Patient (2687)
Date of Event	05/09/2025
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that the patient had original surgery back in (b)(6) 2023 by a different surgeon.The patient experienced pain and it was noticed that his central screw broke and therefore needed to have a revision surgery.The surgeon removed the reverse shell and poly to gain exposure to the glenoid.The glenosphere was removed, peripheral screws were removed and the proximal portion of the central screw was removed however, the broken end of the screw was retained.The surgeon then redrilled and reamed the glenoid for a new implant and with less superior tilt.A new baseplate was utilized a new central screw as well, and peripheral screws.The surgeon chose to go up on glenosphere size to a 36+4, a new lg +0 shell was implanted with a new poly as well.There was no allegation that the product was defective.Affected side: left shoulder.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.A manufacturing record evaluation (nc search) was performed for the finished device product code:550035600, lot -207727 and no non-conformances / manufacturing irregularities were identified.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot: a manufacturing record evaluation (nc search) was performed for the finished device product code:550035600, lot -207727 and no non-conformances / manufacturing irregularities were identified.Added: b5.
Event or Problem Description
Additional information was received: was the patient experiencing any adverse symptoms/consequence that led to the revision surgery? yes, patient started having pain that caused him to seek follow up.

• Brand Name: CENTRAL SCREW 6.0X35
• Common Device Name: SHOULDER IMPLANT - SCREW
• 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: 22140559
• Report Number: 1818910-2025-08992
• Device Sequence Number: 7060510
• Product Code: PHX
• UDI-Device Identifier: 10603295548805
• UDI-Public: (01)10603295548805(17)270930(10)207727
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K212737
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 550035600
• Device Lot Number: 207727
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/12/2025
• Supplement Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male