MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 DXTEND SCREW NO LOCK D4.5X24MM; DELTA XTEND IMPLANTS : SCREWS

Catalog Number 130770024

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 04/16/2024

Event Type  Injury  

Event Description

Subject id: (b)(6).Study no: dots clinical adverse event received for infection.Event is serious and is considered moderate.Event is not related to device or procedure.Date of implant: (b)(6) 2024 date of event: (b)(6) 2024 (right shoulder) treatment: injected medication.

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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.A search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product# 130770024/lot# 5612447 combination.Additionally sterilization records were review and no issues were found.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 a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product# 130770024/lot# 5612447 combination.Additionally sterilization records were review and no issues were found.

• Brand Name: DXTEND SCREW NO LOCK D4.5X24MM
• Type of Device: DELTA XTEND IMPLANTS : SCREWS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19203205
• MDR Text Key: 341287694
• Report Number: 1818910-2024-09391
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295027799
• UDI-Public: 10603295027799
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K192855
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/29/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 130770024
• Device Lot Number: 5612447
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2024
• Initial Date FDA Received: 04/29/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DXTEND GLENOSPHERE ECC D42MM.; DXTEND METAGLENE.; DXTEND MOD EPI 2 ECC RIGHT HA.; DXTEND MODULAR HUM STEM D14 HA.; DXTEND SCREW LOCK D4.5X36MM.; DXTEND SCREW LOCK D4.5X48MM.; DXTEND SCREW NO LOCK D4.5X24MM.; DXTEND STAND PE CUP D42 +3MM.
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 108 KG