MAUDE Adverse Event Report: DEPUY MITEK 5.5 HEALIX ADVANCE BR 3 SUTURE ANCHOR W/ ORTHOCORD; ANCHOR IMPLANTS

Catalog Number 222298

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

The complaint device has been received and is currently being investigated.When the evaluation results are available, a follow up medwatch report will be filed.Under investigation.

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 device in question is now put under the acromion.The surgeon reported that he had inserted the device properly.There is no pain with the patient and he is under observation.Revision has not been planned yet.The following additional information was received from our affiliate via e-mail on (b)(6) 2015.The date of the original procedure is unknown.The revision surgery occurred on (b)(6).The affiliate indicated that they were notified of the event sometime in (b)(6).The affiliate provided product code 222298 for the failed device but the lot number of the device is unknown.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 (b)(6) 2015.Affiliate has also indicated that the revision surgery took place on (b)(6) and the device in question will be returned for investigation.

Manufacturer Narrative

The complaint device was received and evaluated.It was noted that only the anchor had been returned.The suture and inserter were not returned.Inspection of anchor distal tip reveals a small crack in the anchor.The proximal end of the anchor has been flattened.This was probably caused by the removal of the anchor or could have happened in transit.The threads on the anchor appear stressed consistent with it being inserted into the bone.It can be confirmed that this anchor pulled out.Typically, anchor pull outs are associated with incomplete insertion into the bone hole, using instruments not indicated to be used with the anchor, poor bone quality and applying excess force on suture during tensioning.Although we cannot discern a root cause, any of the aforementioned factors or a combination of factors could possibly lead to this failure.This complaint can be confirmed.A batch review was not conducted as the batch number is unknown.However, depuy synthes 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 device in question is now put under the acromion.The surgeon reported that he had inserted the device properly.There is no pain with the patient and he is under observation.Revision has not been planned yet.The following additional information was received from our affiliate via e-mail on 9/8/2015.The date of the original procedure is unknown.The revision surgery occurred on (b)(6).The affiliate indicated that they were notified of the event sometime in (b)(4).The affiliate provided product code 222298 for the failed device but the lot number of the device is unknown.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.Affiliate has also indicated that the revision surgery took place on (b)(6) and the device in question will be returned for investigation.

• Brand Name: 5.5 HEALIX ADVANCE BR 3 SUTURE ANCHOR W/ ORTHOCORD
• 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: dennis mcgovern ; 325 paramount drive; quality department; raynham, MA 02767 ; 8008283716
• MDR Report Key: 5102197
• MDR Text Key: 26715687
• Report Number: 1221934-2015-00987
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K120078
• 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
• Type of Report: Followup
• Report Date: 08/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 222298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2015
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/28/2015
• Event Location: Hospital
• Date Report to Manufacturer: 08/28/2015
• Date Manufacturer Received: 08/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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; Required Intervention