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 Date 08/12/2014

Event Type  Injury  

Event Description

The patient reported that approximately 6 weeks post op she felt that the intrafix sheath and screw she had implanted was uncomfortable , was hanging out too much and she could feel it under the skin.She reported that it was not painful and she did not receive any treatment for the condition.The patient reported that she had full motion of the knee but whenever she would kneel it was be more prominent and uncomfortable.The patient reported she had the implants removed and has sent in pictures of the devices.The patient did not have lot numbers or product codes for the complaint devices.The patient reported that no other fixation device was utilized.See associated medwatch # 1221934-2014-00395.

Manufacturer Narrative

The complaint device was not returned.However the picture provided reveals that partial implant was removed during re-surgery.The original surgery notes do not indicate any anomalies in the technique.There was no information provided regarding the re-surgery when the implants were removed.There were no new screws used implying the acl fixation was successful.Furthermore, no lot numbers were supplied which precludes conducting a batch history review or a lot specific search in the complaints handling system.A root cause for this issue cannot be determined.Based on the complaint history, no further action is warranted.Should additional information be available in future, this complaint will be reopened and re-evaluated.However, depuy 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: 4082868
• MDR Text Key: 18292426
• Report Number: 1221934-2014-00394
• 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: Other,Health Professional,Company Representative,Distributor
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2014
• 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
• Distributor Facility Aware Date: 08/12/2014
• Event Location: Hospital
• Date Report to Manufacturer: 08/18/2014
• Date Manufacturer Received: 08/18/2014
• 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