MAUDE Adverse Event Report: ARTHREX, INC. BIOCOMPOSITE INTERFERENC SCREW W/ DISP SHEATH; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number AR-1370C

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

Patient Problem Pain (1994)

Event Date 01/21/2014

Event Type  Injury  

Event Description

It was reported that at the post-op visit after a pcl reconstruction, the patient complained of pain in his knee.From an x-ray, the surgeon discovered that there were six threads out of the bone and that the screw was broken.It was undetermined if the screw broke during insertion or post op.The doctor felt that it remained secure and did not perform a revision surgery.He removed the broken piece.Prior to that, he performed a double bundle with a whip stitch over the medial bone bridge and felt it would hold the fixation.

Manufacturer Narrative

Patient demographics (age at time of event, 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.Lot number was not provided so device history record review cannot be performed.Per the event description, it was undetermined if the screw broke during insertion or post op.Implant breaking intra-operatively is typically caused by not inserting the implant co-axial to the bone tunnel, prying/leveraging the implant, flexing the joint during insertion or improper bone preparation.Implant breaking post-operatively is most likely caused by implanting the device too deep in the tunnel during the initial surgery which causes the tip to be exposed into the joint.This unsupported tip can be impinged by the graft and/or bone over time and/or not inserting an intact device during intra-operatively causing the device to migrate into the joint.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.

• Brand Name: BIOCOMPOSITE INTERFERENC SCREW W/ DISP SHEATH
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 194
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 194
• Manufacturer Contact: vik bajnath, sr. mdr analyst. ; 1370 creekside boulevard; naples, FL 34108-1945 ; 8009337001
• MDR Report Key: 3630170
• MDR Text Key: 3986470
• Report Number: 1220246-2014-00012
• 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,Distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 01/21/2014

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 Catalogue Number: AR-1370C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/21/2014
• Initial Date FDA Received: 02/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other