MAUDE Adverse Event Report: ARTHREX, INC. BIOCOMPOSITE INTERFERENC SCREW, FULL THREAD; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number AR-1380TC

Device Problem Detachment Of Device Component (1104)

Patient Problem Nerve Damage (1979)

Event Date 08/19/2014

Event Type  Injury  

Event Description

It was reported that about 18 months after an acl reconstruction, a part of the bio-comp.Interference screw (tibial fixation) was found inside patient´s knee joint and caused cartilage damage.The fragment was removed in a second surgery.It was implanted in (b)(6) 2013 and fragment removed in (b)(6) 2014.At the moment no further information is available.

Manufacturer Narrative

Patient demographics (date of birth) was 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.Based on the information provided, the most likely cause(s) of this event is damage and/or under or over insertion of the implant at the time of implanting which led to the breakage and post-op fragment in the joint space.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.Unknown device disposition.

• Brand Name: BIOCOMPOSITE INTERFERENC SCREW, FULL THREAD
• 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: 4081204
• MDR Text Key: 4853508
• Report Number: 1220246-2014-00161
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K071176
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 08/19/2014

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-1380TC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/19/2014
• Initial Date FDA Received: 09/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 31 YR
• Patient Weight: 50