MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 LOCKING SCREW 25; SHOULDER IMPLANT - LOCKING SCREW

Catalog Number	550310025
Medical Device Problem Codes	Difficult to Insert (1316); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the 25mm locking screw was defective.The head of the screw passed through the baseplate without locking into the baseplate.The surgical delay is unknown.Affected side: right shoulder.
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 j&j medtech, or its employees that the report constitutes an admission that the product, j&j medtech, 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: no device associated with this report was received for examination.Product description: - locking screw 25.Product code: - 550310025.Lot no: - 229908.Quantity of manufactured- (b)(4).Date of manufacturing- manufacture and secondary processing completed on 1/7/2025.Order closed through vendor packaging and sterilization on 2/3/2025.Ant anomalies or deviations identified in dhr- none.Expiry date- 2029-12-31 per label.Ifu reference- no ifu referenced on packaging print (b)(6).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: product description: - locking screw 25 product code: - 550310025, lot no: - 229908, quantity of manufactured- (b)(4).Date of manufacturing- manufacture and secondary processing completed on 1/7/2025.Order closed through vendor packaging and sterilization on 2/3/2025.Ant anomalies or deviations identified in dhr- none.Expiry date- 2029-12-31.Per label ifu reference- no ifu referenced on packaging print (b)(6).Device history review: a manufacturing record evaluation was performed for the finished device, and no non-conformances / manufacturing irregularities related to the malfunction were identified.

• Brand Name: LOCKING SCREW 25
• 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 ; 9083863534
• MDR Report Key: 22009615
• Report Number: 1818910-2025-07712
• Device Sequence Number: 14759543
• Product Code: HSD
• UDI-Device Identifier: 10603295546580
• UDI-Public: (01)10603295546580(17)291231(10)229908
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 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: 550310025
• Device Lot Number: 229908
• 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: 04/22/2025
• Supplement Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/09/2025
• 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: 68 YR
• Patient Sex: Female
• Patient Weight: 59 KG