MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 DXTEND SCREW LOCK D4.5X42MM; DELTA XTEND IMPLANTS : SCREWS

Catalog Number 130790042

Device Problem Fracture (1260)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/03/2024

Event Type  malfunction  

Event Description

It was reported that the nut fell out of a center locking screw and had to open a new one.Unknown surgical delay.Doe: (b)(6) 2024.Affected side: left shoulder.

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).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 reconstruction, 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.

Event Description

Additional information was received and states that there was no harm to the patient.It also states that there was a slight delay.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary - no device associated with this report was received for examination.The dhr analysis of the batch returned shows an initial conformance of this product with regards to its specification.For this batch lot number: 5621695 and product code:130790042, there was no deviation or non-conformance.This analysis has not highlighted any chaumont defect: the need of corrective actions is not indicated.Statistical analysis ¿ similar case non applicable.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 - the dhr analysis of the batch returned shows an initial conformance of this product with regards to its specification.For this batch lot number: 5621695 and product code:130790042, there was no deviation or non-conformance.

• Brand Name: DXTEND SCREW LOCK D4.5X42MM
• 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): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18491036
• MDR Text Key: 332608111
• Report Number: 1818910-2024-00816
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295027867
• UDI-Public: 10603295027867
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192855
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/11/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 130790042
• Device Lot Number: 5621695
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2024
• Initial Date FDA Received: 01/11/2024
• Supplement Dates Manufacturer Received: 01/11/2024; 01/24/2024
• Supplement Dates FDA Received: 01/12/2024; 01/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2023
• 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