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

Catalog Number AR-1927BCF

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/16/2015

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/is expected for evaluation but has not yet been received.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.Complainant's event typically caused by over-insertion, 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 the device is returned and additional information is obtained, a follow-up report will be submitted.

Event Description

It was reported that a 5.5mm biocomposite corkscrew suture anchor was selected for use in a rotator cuff surgery.Upon insertion of the anchor, the device threads sheared off.The broken pieces from the anchor was not retrieved from the patient.Follow-up investigation: when inserting the ar-1927bcf anchor, the anchor went in fine but its threads peeled off a bit while going in, producting small debris.The anchor held and was used to complete the repair.No x-ray was taken.

• Brand Name: SUTURE ANCHOR, BIO-CORKSCREW FT
• 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: 5309558
• MDR Text Key: 33833182
• Report Number: 1220246-2015-00365
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 12/01/2015

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: 07/01/2017
• Device Catalogue Number: AR-1927BCF
• Device Lot Number: 10002090
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/01/2015
• Initial Date FDA Received: 12/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2015
• 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