MAUDE Adverse Event Report: DEPUY MITEK MITEK ACL IMPLANTS

Catalog Number UNK MILAGRO SCREW

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

Patient Problem Unknown (for use when the patient's condition is not known) (2202)

Event Type  Injury  

Event Description

The following issue was discovered via a published cohort study by the mitek safety officer 3 years after having acl reconstruction between 2007-2008 using mitek milagro anchors.Author: charles l.Cox, md, mph, kurt p.Spindler, md, james p.Leonard, md, brent j.Morris, md, warren r.Dunn, md, mph, and emily k.Reinke, phd.Reference: the journal of bone & joint surgery d jbj s.Org.Do newer generation bioabsorbable screws become incorporated into bone after acl reconstruction? investigation performed at vanderbilt sports medicine, vanderbilt university medical center, nashville, tennessee.Cyst found upon radiological investigation by researching doctor.Cyst treatment not presented in paper.

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 remains 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: 4731649
• MDR Text Key: 5586476
• Report Number: 1221934-2015-00724
• Device Sequence Number: 1
• Product Code: HWC
• 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: 03/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK MILAGRO SCREW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/31/2015
• Event Location: Hospital
• Date Report to Manufacturer: 03/31/2015
• Date Manufacturer Received: 03/31/2015
• 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