MAUDE Adverse Event Report: DEPUY MITEK MITEK RIGIDFIX CROSS PIN; ACL IMPLANTS

Catalog Number UNK RIGIDFIX

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

Patient Problems Rupture (2208); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

Mitek medical affairs department discovered this published white paper detailing a historical event in which some mitek devices were implicated.It cannot be confirmed that this issue had been previously reported to mitek, so an adverse event report is being filed to document the experience described in the article.At this point in time, no further action is warranted.However, this file will remain receptive to any potential forthcoming information received that is pertinent and germane to this issue.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.

Event Description

This complaint was forwarded to mitek complaints by our medical affairs team who reviewed a journal article where mitek rigidfix cross pins were used for an acl reconstruction for a (b)(6) male.He had reconstruction surgery 9 years ago.Revision surgery was performed 4 years ago for a re-ruptured acl.A third re-vision surgery was done in another hospital.Within (b)(6), the patient experienced pain and swelling and was referred to a different hospital where emergency surgical exploration was performed.A greter saphenous vein autograft was harvested from the ipsilateral limb and a reanastomosis procedure was performed.(b)(4) knee surgery & related research popliteal artery pseudoaneurysm after anterior cruciate ligament re-revision using a rigidfix cross pin authors: gwang chul lee, md dong hwi kim, md sung-hae park, md.

• Brand Name: MITEK RIGIDFIX CROSS PIN
• Type of Device: ACL IMPLANTS
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; quality department; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK; 325 paramount drive; na; raynham MA 02767
• Manufacturer Contact: darlene silvia ; 325 paramount drive; quality department; raynham, MA 02767 ; 8003824682
• MDR Report Key: 5027904
• MDR Text Key: 23955334
• Report Number: 1221934-2015-00933
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Report Date: 08/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK RIGIDFIX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/06/2015
• Event Location: Hospital
• Date Report to Manufacturer: 08/06/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/25/2015
• 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?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 29 YR