MAUDE Adverse Event Report: DEPUY MITEK MITEK ABSORBABLE ANCHOR IMPLANT; ANCHOR IMPLANTS

Device Problem Detachment Of Device Component (1104)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

The complaint device is not available for a physical evaluation and therefore a root cause for this failure cannot be discerned.It was only reported that an unknown healix anchor was used in the procedure.Furthermore, no lot numbers were supplied which precludes conducting a batch history review or a lot specific search in the complaints handling system.At this point in time, no further action is warranted.Till date, no follow up information has been provided regarding patient condition.However, should any new information be provided in future, this file will be re-opened and a thorough investigation will be performed.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.

Event Description

It was reported that after arcr surgery the surgeon found by images that the device inserted outside the greater tubercle of humerus had come off although the patient was going to leave the hospital soon.The surgeon reported that he had inserted the device properly.Revision has already taken place and the surgeon removed the device in question.It was discarded at the hospital.The patient is now under observation.The following additional information was received from our affiliate via e-mail on 9/8/2015.The dates of the original procedure and revision surgery are unknown.The affiliate indicated that they were notified of the event sometime in august.Both the product code and lot number of the device are unknown to the affiliate.The surgeon used an awl to prepare the bone hole.The device had pulled out of the bone hole and it is unknown if another like device was used to complete the procedure.The affiliate was able to provide the alert date as august 28, 2015.

• Brand Name: MITEK ABSORBABLE ANCHOR IMPLANT
• Type of Device: ANCHOR 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: 5101772
• MDR Text Key: 26716063
• Report Number: 1221934-2015-00989
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Report Date: 08/28/2015

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/28/2015
• Event Location: Hospital
• Date Report to Manufacturer: 08/28/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/24/2015
• 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