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	Bone Fracture(s) (1870)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint: (b)(4).Investigation summary: no device associated with this report was received for examination.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 records evaluation (mre) was not perform.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: there is 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: d1, d10 (concomitant).
Event or Problem Description
Subject id: (b)(6), study no: (b)(4).Clinical adverse event received for displaced type 2b scapular spine fracture device (relatedness): probable procedure (relatedness): causal relationship date of event: 23 feb 2023 date of implant: no information provided date of revision: (b)(6) 2025 device location: no information provided.Treatment/impact: surgical intervention for the registry shoulder: yes, date of surgical intervention: 18 mar 2026, open reduction internal fixation (orif): yes, components removed (mark none or all that apply.) :(* please complete a patient completion/discontinuation formnbsp; none: yes.Depuy synthes products used: type: screw catalog number: 130960315 lot number: rl295828 description: central metaglene screw 6mm x 15mm.Type: screw catalog number: 130790024 lot number: 5547930 description: delta xtend locking screw 4.5 x 24.Type: screw catalog number: 130770018 lot number: 5819790 description: delta xtend non-locking screw 4.5 x 18.Type: screw catalog number: 130790024 lot number: 5552950 description: delta xtend locking screw 4.5 x 24.Type: screw catalog number: 130770018 lot number: 5829670 description: delta xtend non-locking screw 4.5 x 18.Type: collet catalog number: 130960111 lot number: rl304653 description: central screw metaglene collet.Type: shell catalog number: 130738203 lot number: 5568017 description: delta xtend humeral cup std.38 x+3.Type: epiphysis catalog number: 130720111 lot number: 4093704 description: xtend modular eccentric 145 epi porocoat size 1.Type: metaglene catalog number: 130970850 lot number: 4117257 description: augmented central screw metaglene full wedge.Type: glenosphere catalog number: 130761138 lot number: d22072589 description: standard glenosphere 38mm, +0 lateralization.
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: a1:(b)(4).

• 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: 25033955
• Report Number: 1818910-2026-07853
• Device Sequence Number: 9323024
• Product Code: HSD
• UDI-Device Identifier: 10603295027782
• UDI-Public: (01)10603295027782(17)291130(10)5819790
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Study,Health Professional
• 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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 130770018
• Device Lot Number: 5819790
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/14/2026
• Supplement Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 04/29/2026
• Supplement Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/13/2024
• 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: AUG CTR SCREW META FULL WEDGE; CTR METAGLENE SCREW 6MM X 15MM; CTR SCREW METAGLENE COLLET; DXTEND SCREW LOCK D4.5X24MM; DXTEND SCREW LOCK D4.5X24MM; DXTEND SCREW NO LOCK D4.5X18MM; DXTEND STAND PE CUP D38 +3MM; XTEND MOD CEN 145EPI POR SZ1; XTNDGLENO D38MM +0MM SHRTPST
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female