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

(b)(4).Reference: almazan a, herrera jp, chaidez c, cruz f, perez f, ibarra c.A complication of soft tissue graft tibial fixation with the intrafix device.Med sci monit.2009 jan;15(1):cs19-21.(b)(6).Patient characteristics: age: 43; gender: male; index operation: aclr (hamstring graft), chronic tear; devices: rigidfix + peek intrafix before 8 wks.Time of complication: before 8 wks.Type of complication: femoral tunnel screw divergence and migration.Joint: knee.Device: peek intrafix.Suture: na.Other devices: na.Signs and symptoms: progressive loss of extension: 10 degree vs.0 degree post-op, pain, crepitus in the antero-medial aspect of right knee (knee was stable) tissue damage: healthy looking acl graft which was impinged by fibrous tissue, tip of intrafix in the medial tibia plateau (mtp), implant was outside the original tibial tunnel and created a false way, 1.5x1.5 cm grade iii chondral injury on the lateral aspect of the medial femoral condyle (mfc).Imaging studies: x-ray: adequate tunnel position and no other finding.Reoperation (related/unrelated): excision of screw with forceps.Medical treatment: antibiotics (but no infection).F/u time: 1 wk.Imaging studies: na.Objective outcomes: wound healed, no infection.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: 3773768
• MDR Text Key: 4359706
• Report Number: 1221934-2014-00161
• 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: 04/25/2014
• 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
• Event Location: Hospital
• 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: 43 YR