MAUDE Adverse Event Report: DEPUY MITEK LLC US RIGIDFIX BIOCRYL 3.3 MM FEMORAL ST CROSS PIN KIT; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number 210816

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 06/14/2023

Event Type  Injury  

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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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.Udi: (b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

This is report 4 of 5 for (b)(4).It was reported by a healthcare professional through clinical research that a patient underwent an anterior cruciate ligament reconstruction with meniscal repair procedure of the left knee on (b)(6) 2023 using a rigidfix biocryl 3.3 mm femoral st cross pin kit device.According to the report, the patient had a revision/reoperation procedure on (b)(6) 2023 due to an infection.The status of the patient was unknown.No additional information was provided.

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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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.Investigation summary: the complaint device is not being returned.Therefore, unavailable for a physical evaluation.Since the complaint device was not returned.We cannot determine, a root cause for the reported failure.If additional information or the device is received in the future, we will reopen the complaint.And perform the investigation as appropriate.A manufacturing record evaluation was performed, for the finished device lot number #:(9l05298).And no non-conformances were identified.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints, within this device family as a means of monitoring.The extent with which, this complaint is observed in the field.

• Brand Name: RIGIDFIX BIOCRYL 3.3 MM FEMORAL ST CROSS PIN KIT
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• 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: 17310559
• MDR Text Key: 318929677
• Report Number: 1221934-2023-02711
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705001309
• UDI-Public: 10886705001309
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 210816
• Device Catalogue Number: 210816
• Device Lot Number: 9L05298
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female