MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMPR INTERF SCRW,FULL THD; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number AR-1400TC

Device Problems Break (1069); Detachment Of Device Component (1104); Crack (1135)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/31/2015

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 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.Complainant's event is typically caused by not inserting the implant co-axial to the bone tunnel, prying or leveraging while still loaded, improper bone preparation or flexing the joint during insertion.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.Discarded by the facility.

Event Description

It was reported that during a revision surgery for a re-injured anterior crucuiate ligament, the surgeon removed the existing device (another manufacturer's washer lock).He attempted to insert the bio-composite screw to achieve tibial fixation of an achilles allograft.During insertion of the screw, at approximately 1/4 to 1/2 of the way in, the screw cracked in half horizontally.About 10mm was inserted before the remainder broke-off.Surgeon did not attempt to remove the portion that remained as it was securely seated.He attempted to insert a 23mm screw distally, however, he was not successful in doing so.Instead he inserted another manufacturer's cortical screw and washer for secondary fixation placed in the tibia, distal to the bio-composite screw that broke.

• Brand Name: BIO-COMPR INTERF SCRW,FULL THD
• 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: 5030877
• MDR Text Key: 24048113
• Report Number: 1220246-2015-00216
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071176
• 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
• Report Date: 07/31/2015

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: 04/01/2017
• Device Catalogue Number: AR-1400TC
• Device Lot Number: 1240205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/26/2015
• 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