MAUDE Adverse Event Report: DEPUY MITEK MITEK ACL IMPLANTS

Catalog Number UNK INTRAFIX

Device Problem Unknown (for use when the device problem is not known) (2204)

Patient Problem Surgical procedure, repeated (2042)

Event Type  Injury  

Event Description

Author: lee (2011) south korea reference: lee kb, song sy, paik sh, shin wh.Delayed intra-articular migration of the intrafix outer sheath after anterior cruciate ligament reconstruction: a case report.Knee.2011 oct;18(5):347-9.(b)(6).Patient characteristics: age: (b)(6).Gender: female.Index operation: acl repair (8.5-mm tibialis allograft), partial menisectomy devices: bioabsorbable rigidfix and 9-mm non-absorbable intrafix (4 separate channels for graft) + post-tie staple time of complication: 5 mo.Type of complication: migration of the outer sheath into the joint joint: knee.Device: intrafix.Suture: na.Other devices: na.Signs and symptoms: 5 months: sudden catching sensation and slight pain with swelling exam: full range of motion and mild effusion, lachman test: 1+ with a solid endpoint, pivot test negative 6 months: moderate effusion, rom: 20° to 130°, lateral joint line tenderness.Tissue damage: labs showed no signs of infection.Reactive synovitis.Acl graft had a small portion of disruption but good incorporation.Sheath anchored to the intra-articulr opening of the tibial tunnel.Imaging studies: x-rays: no tunnel enlargement.Reoperation (related/unrelated): aspiration 60 cm3 of serous fluid, culture negative.Removal of intrafix sheath in several pieces.Debridement of disrupted graft fibers (<10%), synovectomy.Removal of intrafix screw through tibial cortex (related).Medical treatment: - na.F/u time: - na.Imaging studies: - na.Objective outcomes: - na.Functional outcomes: - na.Subjective outcomes: - na.

Manufacturer Narrative

Mitek medical safety 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.

• Brand Name: MITEK ACL IMPLANTS
• 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: siri belur ; 325 paramount drive; quality department; raynham, MA 02767 ; 8003824682
• MDR Report Key: 3759491
• MDR Text Key: 17261256
• Report Number: 1221934-2014-00143
• 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: Literature,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK INTRAFIX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/31/2014
• Event Location: Hospital
• Date Report to Manufacturer: 01/31/2014
• Date Manufacturer Received: 01/31/2014
• 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): Required Intervention
• Patient Age: 48 YR