MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DXTEND SCREW LOCK D4.5X30MM; DELTA XTEND IMPLANTS : SCREWS

Catalog Number	130790030
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the delta screw broke during insertion.Surgery was delayed by five minutes.A new screw was used, and the procedure was completed successfully.Fragments were easily removed without requiring additional intervention.There was no patient consequence.
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.H11 additional narrative: d4: udi: as a valid lot number for the device involved in the event was not provided, the full udi is currently not available.
Additional Manufacturer Narrative
Product complaint #: investigation summary: delta screw broke during insertion.The product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found that the dxtend screw lock d4.5x30mm has one of the flanges of his head fracture, additionally the prongs of the rest of the head of the screw were damage and or fractured, furthermore the distal tip shows signs of damage consistent with the implantation process.Not all fracture fragments were returned for evaluation.A manufacturing record evaluation was performed for the finished device product description: dxtend screw lock d4.5x30mm product code: 130790030 lot number: 5819299 and no non-conformances or manufacturing irregularities were identified.Although a definitive cause for the implant (screw) fracture is not established, there are many factors that could have contributed to this type of damage, including the possibility of an off-axis assembly or by loosing contact of the screwdriver's tip with the fines of the screw potentially resulting in uneven torque application if protective sleeve is not used, as per delta xtend¿ reverse shoulder system surgical technique care notes (pages 19-23).Therefore, with information provided the mode of failure of the device is multi-factorial and consideration must be given to all other potential influences during surgical process.A functional test was unable to be performed due to the post-manufacturing damage.A dimensional inspection was unable to be performed due to the post-manufacturing damage.The overall complaint was confirmed as the observed condition of the dxtend screw lock d4.5x30mm would have contributed to the complained 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 j&j medtech orthopaedics 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 product description: dxtend screw lock d4.5x30mm product code: 130790030 lot number: 5819299 and no non-conformances or manufacturing irregularities were identified.Device history review: a manufacturing record evaluation was performed for the finished device product description: dxtend screw lock d4.5x30mm product code: 130790030 lot number: 5819299 and no non-conformances or manufacturing irregularities were identified.Corrected: d4 (primary udi #), h3.Added: d4 (lot, expiration), h4.

• Brand Name: DXTEND SCREW LOCK D4.5X30MM
• 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: 22174650
• Report Number: 1818910-2025-09362
• Device Sequence Number: 7957835
• Product Code: HSD
• UDI-Device Identifier: 10603295027843
• UDI-Public: (01)10603295027843(17)291130(10)5819299
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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: 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: 130790030
• Device Lot Number: 5819299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/15/2025
• Supplement Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2024
• 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
• Patient Sex: Unknown