MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMPOSITE CORKSCREW; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number AR-1927BCF-3

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/11/2016

Event Type  Injury  

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 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 includes improper bone preparation for the hardness of bone encountered, not inserting the implant co-axial to the bone tunnel and/or prying/leveraging the driver while the implant is still loaded.This is the second 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 that an ar-1927bcf-3, 5.5x14.7mm biocomposite corkscrew ft suture anchor, was used for a hind-foot reconstruction and peroneal tendon repair procedure.The surgeon had punched and tapped to prepare for insertion of the anchor.When the surgeon was inserting the anchor into the patient, the anchor was being inserted into the distal fibula but started breaking at its proximal end with about 4-5 mm still exposed.Approximately 3 mm of the proximal end broke-off into 2 pieces.The surgeon tried backing out the anchor but it would not back out.This was an open procedure with good visibility and the broken pieces were retrieved.Surgeon pulled on the remaining portion of the anchor that was left in the patient to insure it was fully inserted and test the strength.Nothing further was done to secure the anchor.The procedure was completed using eyed needles to sew the threads into the tendon and fastened as usual.

• Brand Name: BIO-COMPOSITE CORKSCREW
• 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: vikram bajnath, sr mdr analyst ; 1370 creekside boulevard; naples, FL 34108-1945 ; 8009337001
• MDR Report Key: 5630014
• MDR Text Key: 44349922
• Report Number: 1220246-2016-00199
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K082810
• 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: 04/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2017
• Device Catalogue Number: AR-1927BCF-3
• Device Lot Number: 400655
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2015
• 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