MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, BIO-COMP. PUSHLOCK; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number AR-2922BC

Device Problems Detachment Of Device Component (1104); Fracture (1260); Material Integrity Problem (2978)

Patient Problem No Code Available (3191)

Event Date 03/15/2016

Event Type  Injury  

Manufacturer Narrative

Patient demographics (date of birth, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.The device was requested for evaluation but was not returned, therefore the complainant's event could not be verified.The cause of the event could not be determined from the information available and without device evaluation.Device history record review revealed nothing relevant to this event.Based on the information provided, the most likely cause(s) of this event may include not inserting the implant co-axial to the bone tunnel or prying/leveraging the driver while the implant is still loaded this is the first complaint of this type for this part/lot combination.The potential cause(s) of this event will be communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.Unknown device disposition.

Event Description

It was reported that a 2.4mm bio-composite pushlock suture anchor, ar-2922bc, lot 1369798, was used for a labral repair procedure.The hole was pre-drilled for the device and the anchor was inserted.Upon insertion, the surgeon noticed that approximately 1/4 of the last rim of the anchor had fractured off.The piece was removed from the patient.A second pushlock anchor was implanted without issue.A third pushlock anchor, lot 10020105, was inserted into the tunnel but the surgeon reported there was an issue with the integrity of the device.The third anchor was not implanted.An additional six 2.4mm bio-composite pushlock suture anchors were used to complete the procedure.The procedure was completed with six 2.4 peek anchors.

• Brand Name: SUTURE ANCHOR, BIO-COMP. PUSHLOCK
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath, sr. mdr analyst. ; 1370 creekside boulevard; naples, FL 34108-1945 ; 8009337001
• MDR Report Key: 5548255
• MDR Text Key: 41917568
• Report Number: 1220246-2016-00154
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101679
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 03/17/2016

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
• Device Expiration Date: 05/01/2017
• Device Catalogue Number: AR-2922BC
• Device Lot Number: 1369798
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/17/2016
• Initial Date FDA Received: 04/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2015
• 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
• Treatment: AR-2922BC LOT 10020105
• Patient Outcome(s): Other
• Patient Age: 18 YR