MAUDE Adverse Event Report: DEPUY MITEK LLC US RGDFX CRVE ST ACL PLA XPIN SYS; PIN, FIXATION, SMOOTH

Catalog Number 213013

Device Problems Device-Device Incompatibility (2919); Material Deformation (2976)

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

Event Date 09/07/2023

Event Type  malfunction  

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, 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 medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.H10 additional narrative: d4: the expiration date is currently unavailable.Investigation summary
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> the product was returned to mitek for evaluation.Mitek then conducted visual inspection of device received.When performing the visual inspection, the trocar assembly and the sleeve appears heavily used due to it had a lot of marks of wear.The assembly and sleeve were stuck, and it was not possible to disassembled.A manufacturing record evaluation was performed for the finished device lot number: 128l664, and no non-conformances were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.The root cause could be related to procedural variables, such handling of the device or product interaction during procedure.This failure can be attributed to the repeated use of the device causing normal wear and tear.However, it cannot be conclusively affirmed.According to ifu, ensure that the guide block screw is secure, then assemble the first sleeve over the interlocking trocar and position it in the bottom (distal) hole of the guide block.Drill the trocar-sleeve assembly into the medial side of the knee until the sleeve shoulder meets the guide block.As the trocar-sleeve assembly advances forward, make sure that it stays engaged, and that both elements are spinning together.This ensures that the cross pins are placed in the correct location with respect to the femoral tunnel.Place the guide pin at the appropriate position on the superior rim of the femoral notch.The trocars do not cross the femoral tunnel or penetrate bone on the other side.The sleeves do not enter the femoral tunnel.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.Udi:(b)(4).

Event Description

It was reported by the healthcare professional in italy that during an anterior cruciate ligament (acl) repair procedure on (b)(6) 2023 it was observed that during the insertion of the sleeve into the guide of the rigidfix curve st acl pla cross pin system device, the trocar melted with the sleeve.During in-house engineering evaluation, it was determined that the device was stripped/worn/twisted/cross threaded.Another like device was used to complete the procedure.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.

• Brand Name: RGDFX CRVE ST ACL PLA XPIN SYS
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 18519034
• MDR Text Key: 333378652
• Report Number: 1221934-2024-00119
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K130105
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/16/2024

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: 213013
• Device Lot Number: 128L664
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2024
• Initial Date FDA Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2023
• 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