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 09/05/2023

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.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: investigation summary: only one sleeve and trocar assembly were received for evaluation.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 is not possible to dissembled.A manufacturing record evaluation was performed for the finished device lot number 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.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.

Event Description

It was reported by the affiliate in italy that during an unspecified surgical procedure, the rgdfx crve st acl pla xpin sys device during the insertion of the sleeve into the guide, the trocar melted with the sleeve.During in-house engineering evaluation, it was determined that the device was stripped/worn/twisted/cross threaded.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: 18505574
• MDR Text Key: 333213430
• Report Number: 1221934-2024-00106
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/12/2024

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
• Initial Date Manufacturer Received: 01/11/2024
• Initial Date FDA Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1