MAUDE Adverse Event Report: ARTHREX, INC. IMPLANT DELIVERY SYSTEM, DISTAL BICEPS REPAIR; PLATE, FIXATION, BONE

Catalog Number AR-2260

Device Problem Break (1069)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 12/16/2014

Event Type  Injury  

Event Description

It was reported that the original date of surgery was approximately mid (b)(6) 2014.About two weeks post-op, patient noticed a deformity in the bicep muscle.Another surgery was done about two weeks later as the suture had broken.Another ar-2260 was used in the patient; the original button was not removed.

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 remains in the patient and cannot be 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.The most likely cause of this type of event is patient non-compliance with the post-op protocol, damage to the device during insertion (nicking the suture with another instrument and/or fraying from sharp edge of the bone tunnel) and/or improper placement.Arthrex makes no claims for suture strength when part of a device.The product directions for use (dfu-0111) states: post-operatively and until healing is complete, the fixation provided by this device should be protected.The post-operative regimen prescribed by the physician should be strictly followed to avoid adverse stresses applied to the implant.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.Part remained in patient.

• Brand Name: IMPLANT DELIVERY SYSTEM, DISTAL BICEPS REPAIR
• Type of Device: PLATE, FIXATION, BONE
• 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: 4510398
• MDR Text Key: 5444761
• Report Number: 1220246-2015-00014
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062747
• 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: 01/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2019
• Device Catalogue Number: AR-2260
• Device Lot Number: 1185817
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2014
• 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: 35 YR