MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 DXTEND SCREW LOCK D4.5X42MM; DELTA XTEND IMPLANTS : SCREWS

Catalog Number	130790042
Medical Device Problem Codes	Fracture (1260); Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2025
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.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.
Event or Problem Description
It was reported that during a reverse shoulder arthroplasty surgical procedure, it was observed that the screw threads peeled and could not lock.Another device was used to complete the surgery.There were no adverse consequences to the patient.No additional information could be provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: could not lock&thread peeled.It was reported that during the surgery, noted the screw threads peeled and could not lock (as the attached photo shows).Another device was used to complete the surgery.There were no adverse consequences to the patient.No additional information could be provided.The product was not returned to depuy synthes; however, photos were provided for review.The photo investigation revealed that the head of the dxtend screw lock d4.5x42mm has fractured some of the tabs, which would lead with assembling issues.No other anomalies were noted.With information provided, a specific root cause cannot be established.The mode of failure of the device is multi-factorial and consideration must be given to all other potential influences during the surgical process.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.As the device was not returned, and as-received condition could not be assessed, a dimensional inspection and document/specification review were not completed.A manufacturing record evaluation was performed for the finished device 5638487 number, and no non-conformances / manufacturing irregularities were identified during manufacturing.The overall complaint was confirmed as the observed condition of the dxtend screw lock d4.5x42mm would have contributed to the complained device issue.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: a manufacturing record evaluation was performed for the finished device 5638487 number, and no non-conformances / manufacturing irregularities were identified during manufacturing.Added: d4 (expiration date), h4.Corrected: d4 (primary udi number).

• Brand Name: DXTEND SCREW LOCK D4.5X42MM
• Common Device Name: DELTA XTEND IMPLANTS : SCREWS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• 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: 23995871
• Report Number: 1818910-2026-00339
• Device Sequence Number: 10523357
• Product Code: HSD
• UDI-Device Identifier: 10603295027867
• UDI-Public: (01)10603295027867(17)281031(10)5638487
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,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: 130790042
• Device Lot Number: 5638487
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/22/2025
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/20/2023
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown