MAUDE Adverse Event Report: DEPUY MITEK LLC US RIGIDFIX FEM 3.3MM S/T XPIN; PIN, FIXATION, SMOOTH

Catalog Number 210133

Device Problem Mechanical Jam (2983)

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

Event Date 12/15/2023

Event Type  malfunction  

Event Description

It was reported from italy that during an unknown surgical procedure it was observed that during drilling along the femoral guide, it was observed that the sleeve of the rigidfix fem 3.3mm s/t xpin device melted with the trocar.There were no reports of injuries, medical intervention, or prolonged hospitalization.Another like device was used.No additional information could be provided.This is report 1 of 2 for the same event in (b)(4).

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: h4: the device manufacture date is unknown.(b)(4) as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.

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.H10 additional narrative: h4: the device manufacture date was reported as unknown on the initial report.Please note that the date of manufacture has been updated accordingly.Investigation summary the product was returned to depuy synthes mitek for evaluation.Depuy synthes mitek then conducted visual inspection of the device received.The device was evaluated; upon visual inspection, it was noted that the trocar was jammed into one sleeve, it was not possible to disassembled them.Both show noticeably stretch marks.The rest of the kit was not received.The overall complaint was confirmed as the observed condition of the rigidfix fem 3.3mm s/t xpin would contribute to the complained device issue.Based on the investigation findings the root cause is traced to procedural variables, such handling of the device or product interaction during procedure.Considering that the sleeve as well as the trocar show noticeable stretch marks, we can relate this issue to a bad axis alignment of the drill at the moment of insertion, the bending force applied and the higher spinning speed of the drill can contribute to the jamming condition of the sleeve and trocar.As per instructions for use (ifu): directions for a successfully hole drilling and trocar and sleeve interaction are provided.Therefore it has been determined, 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.

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.The actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.

• Brand Name: RIGIDFIX FEM 3.3MM S/T XPIN
• 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: 18941026
• MDR Text Key: 338443168
• Report Number: 1221934-2024-00931
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 10886705000890
• UDI-Public: 10886705000890
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K974341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 210133
• Device Lot Number: 166L276
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1