MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH,PEEK SWVLKC,4.75X 19.1MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number AR-2324PSLC

Device Problems Break (1069); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/10/2015

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.The complainant's event is typically caused by not inserting the implant co-axial to the bone tunnel, prying/levering 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.

Event Description

It was reported by the facility via a medwatch that on (b)(6) 2015 during a rotator cuff repair, the tip of the guide of the suture anchor was being utilized when the peek tipped eyelet broke off and lodged in the soft tissue.The tip is 2 mm.The surgeon was unable to remove it.Follow-up investigation: procedure was an arthroscopic rotator cuff repair.The surgeon was fixating two fibertape sutures with a 4.75 peek swivelock.After loading the fibertapes through the anchor eyelet and punching a pilot hole for the anchor, the surgeon advanced the anchor into the sub acromial joint space.At this point the surgeon pulled the anchor back up towards the cannula and met some resistance from the fibertape sutures which pulled the eyelet from the swivelock off of the driver and unloaded the #2 fiberwire stay suture.The surgeon used a suture grasper to go back in the joint and retrieve the fibertape sutures with the eyelet still on them however at this point was unable to locate eyelet.The surgeon searched for the eyelet in the soft tissues of the shoulder eventually deciding to leave eyelet.Another 4.75 swivelock anchor of the same lot was opened and used to fixate the fibertape sutures.

• Brand Name: SUTR ANCH,PEEK SWVLKC,4.75X 19.1MM
• 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: 5064025
• MDR Text Key: 25258239
• Report Number: 1220246-2015-00238
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101823
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Risk Manager
• Report Date: 08/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2020
• Device Catalogue Number: AR-2324PSLC
• Device Lot Number: 1425269
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2015
• 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
• Patient Outcome(s): Other
• Patient Age: 60 YR