MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DXTEND SCREW NO LOCK D4.5X18MM; DELTA XTEND IMPLANTS : SCREWS

Catalog Number	130770018
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision of reverse left shoulder.Reason for revision: infection.
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.Additional narrative: d4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information that has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint recon described in this report.H11 additional narrative: added: d4 expiration date, h4.If information that was not available for the initial report is obtained, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint #(b)(4).Investigation summary: revision of reverse left shoulder.Reason for revision ¿ infection.The product was not returned to depuy synthes; however photos were provided for review.See attachment acknowledgement email (b)(4).The photo investigation revealed nothing indicative of a device nonconformance at the dxtend screw no lock d4.5x18mm.The screw was covered with organic material and blood remnants.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was not confirmed as the observed condition of the dxtend screw no lock d4.5x18mm would have not contributed to the reported adverse event.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes 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.Added: d4 expiration date, d10 concomitant, h4.Corrected: d4 primary udi number.

• Brand Name: DXTEND SCREW NO LOCK D4.5X18MM
• Common Device Name: DELTA XTEND IMPLANTS : SCREWS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 23558414
• Report Number: 1818910-2025-19930
• Device Sequence Number: 21372461
• Product Code: HSD
• UDI-Device Identifier: 10603295027782
• UDI-Public: (01)10603295027782(17)291031(10)5799044
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K192855
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 130770018
• Device Lot Number: 5799044
• 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: 10/29/2025
• Supplement Date Received by Manufacturer: 12/04/2025; 01/26/2026
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 12/10/2025; 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/11/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DXTEND HIGHMO PE CUP D42 +3MM.; DXTEND METAGLENE.; DXTEND SCREW LOCK D4.5X24MM.; DXTEND SCREW LOCK D4.5X42MM.; DXTEND SCREW LOCK D4.5X48MM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown