MAUDE Adverse Event Report: ARTHREX, INC. DX BC SUTURE TAK, 2 #0 FW; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number AR-8934BCNF-00

Device Problems Break (1069); Detachment Of Device Component (1104); Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/29/2015

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.Based on the information provided, the most likely cause(s) of this event 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.Device discarded by the facility.

Event Description

It was originally reported that the tips broke-off during insertion on both implants and remained in the bone.The ligament was tied down over the implants.The site was pre-drilled; no other implants were used.Follow-up investigation: the driver tips broke-off during disengagement and withdrawal of driver from both implants after anchors were impacted to the necessary depth.The driver tips and bio-composite anchors remain in the bone.There was an unsuccessful attempt to remove both from the bone, however they were each embedded too far into the bone to successfully remove with minimal bone loss/removal.The suture from the second placed anchor was used to tie down the ligaments over the broken driver tips in the anchors which were left in the bone.The suture from the first implanted anchor was pulled out in the process of the attempted removal of the said anchor.Procedure was an orif fibula/deltoid repair to medial malleolus (portion of procedure where driver of both implants were broken).Case was completed and secondary surgery is unknown.Implants were fully seated.Bone quality was hard.

• Brand Name: DX BC SUTURE TAK, 2 #0 FW
• 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: 5232198
• MDR Text Key: 31452810
• Report Number: 1220246-2015-00318
• 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: 10/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2017
• Device Catalogue Number: AR-8934BCNF-00
• Device Lot Number: 1381107
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2015
• 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: 20 YR