MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DXTEND SCREW LOCK D4.5X36MM; DELTA XTEND IMPLANTS : SCREWS

Catalog Number 130790036

Device Problems Fracture (1260); Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2023

Event Type  malfunction  

Event Description

Locking metaglene screw head detached from the screw and cannot be locked with base plate during surgery.It was tried on patient but removed once defect observed.The screw was not implanted on patient, surgery continued with another screw.There was no surgical delay.

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 which 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.

Manufacturer Narrative

Product complaint #
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> (b)(4) investigation summary
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> according to the information received, locking metaglene screw head detached from the screw and cannot be locked with base plate during surgery.It was tried on patient but removed once defect observed.The screw was not implanted on patient, surgery continued with another screw.The device associated with this report was returned to depuy synthes for evaluation.Visual inspection of the returned sample revealed that no defects were observed in the threads or the tip of the dxtend screw lock d4.5x36mm.The screw was evaluated, and no defects or damage were observed.The screw can be easily screwed and unscrewed in the head of the screw lock.A dimensional inspection was performed for the screw lock and met specifications.A functional test was unable to be performed due to the locking screwdriver not returned.It was not possible to verify if there was any problem with the screwdriver attached to the screw.The complaint condition was not able to be replicated.The overall complaint was unconfirmed as the observed condition of the dxtend screw lock d4.5x36mm would not contribute 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.Drawing: dwg-8e070132 feature: screw head diameter specification: 4.00 -0.10 mm measured dimension: 3.95 mm device used: mitutoyo digimatic caliper a20276546 id# cd78619 drawing: dwg-8e070128 feature: length screw specification: 36.00 +/- 0.20 mm measured dimension: 36.10 mm device used: mitutoyo digimatic caliper a20276546 id# cd78619 device history lot
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> the dhr analysis returned shows an initial conformance of this product with regards to its specification.For this batch, there was no deviation or non-conformance.

• Brand Name: DXTEND SCREW LOCK D4.5X36MM
• Type of Device: DELTA XTEND IMPLANTS : SCREWS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 18300750
• MDR Text Key: 330164801
• Report Number: 1818910-2023-25083
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295027850
• UDI-Public: 10603295027850
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K192855
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 130790036
• Device Lot Number: 5551916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1