MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 DXTEND SCREW LOCK D4.5X42MM; DELTA XTEND IMPLANTS : SCREWS

Catalog Number 130790042

Device Problem Fracture (1260)

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

Event Date 02/21/2024

Event Type  malfunction  

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.

Event Description

It was reported that this was an unknown surgery performed on (b)(6) 2024.The locking screw in question was used for metaglene fixation.When the screwdriver was turned for locking, the inside part came off and could not be locked.It was removed from the body, and a new screw with same size was used for surgery.There was no surgical delay and no harm to the patient.No further information is available.

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.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary: it was reported, that this was an unknown surgery.Performed on (b)(6) 2024.The locking screw in question, was used for metaglene fixation.When the screwdriver was turned for locking, the inside part came off and could not be locked.It was removed from the body.And a new screw with same size was used for surgery.There was no surgical delay.And no harm to the patient.The surgeon requested, to investigate why the part inside came off.No further information is available.The device associated with this report was returned to depuy synthes for evaluation.Visual analysis of the returned device does not found signs of fracture at the dxtend screw lock d4.5x42mm.However, the lockable metaglene screw insert was damaged from the threaded area.The observed, condition of the device was consistent with off axis assembly before is fully engaged.Properly handling and attention to the approved use of the device diminishes the risk of failure.Please refer to the surgical technique delta xtend reverse shoulder system, page 21 "note: use care to ensure, that the driver remains in axial alignment with the screw, so that the driver tip remains fully engaged".A functional test was not performed, since it was not applicable to the complaint condition.A dimensional inspection was not performed, since it was not applicable to the complaint condition.The overall complaint was unconfirmed.As the observed, condition of the dxtend screw lock d4.5x42mm, would not contribute to the complained device issue.Based on the investigation findings, the potential cause is traced to unintended use error.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.Device history lot: a manufacturing record evaluation was performed, for the finished device product description: dxtend screw lock d4.5x42mm, product code#: 130790042, lot number#: 5405631.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 d4.5x42mm, product code#: 130790042, lot number#: 5405631.And no non-conformances or manufacturing irregularities were identified.

• Brand Name: DXTEND SCREW LOCK D4.5X42MM
• Type of Device: DELTA XTEND IMPLANTS : SCREWS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18785481
• MDR Text Key: 336542213
• Report Number: 1818910-2024-04379
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• 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: 5405631
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/03/2022
• 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