MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR BIOCOMPO- SITE PUSHLOCK 2.9X15.5MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number AR-1923BC

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/18/2015

Event Type  Injury  

Event Description

It was reported that the eyelet broke on insertion before it entered bone.The piece of eyelet was retrieved but anchor was not.The anchor was not secured and never entered the bone.It was left floating inside the patient.Another anchor from a different lot was used to complete the case.Follow-up investigation: during a rotator cuff repair; the pushlock's eyelet broke prior to insertion into the glenoid.As the surgeon pulled back to remove the implant, he hit the cannula and pushed the implant off of the inserter.The inflow from the scope pushed the implant out of view.He used another port to search for the implant, but it could not be located.The implant is free floating but not in the joint space.Another implant was used to complete the case.There has not been anything further reported related to this incident.Dos (b)(6) 2015.Patient is doing fine to date.

Manufacturer Narrative

Patient demographics (age at time of event, date of birth, gender, 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 remains in the patient and cannot be 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.The complainant's event is typically caused by not inserting the implant co-axial to the bone tunnel, prying/leveraging or impacting the eyelet against hard bone.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.Part remained in patient.

• Brand Name: SUTURE ANCHOR BIOCOMPO- SITE PUSHLOCK 2.9X15.5MM
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 194
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 194
• Manufacturer Contact: vik bajnath, sr. mdr analyst. ; 1370 creekside boulevard; naples, FL 34108-1945 ; 8009337001
• MDR Report Key: 4593548
• MDR Text Key: 5464941
• Report Number: 1220246-2015-00046
• 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,Distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 02/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2016
• Device Catalogue Number: AR-1923BC
• Device Lot Number: 1183626
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• 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