MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCH BIOCOMP SWI- VELOCK C CLD 4.75X19.1MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number AR-2324BCC

Device Problem Device Slipped (1584)

Patient Problems Foreign Body Reaction (1868); Rash (2033); Synovitis (2094); Osteolysis (2377)

Event Date 01/15/2014

Event Type  Injury  

Event Description

It was reported that following shoulder rotator cuff repair and biceps tenodesis with the plla suture anchors and the fiberwire, the surgeon also found osteolysis, synovitis, loose bodies, anchor pulled out of the bone and a recurrent rotator cuff tear.Three weeks post-op the patient developed a skin reaction on the surgical shoulder and arm.The dermatologist biopsied the areas with results consistent with a foreign body reaction.Patient continued to have issues with pain and the arm/shoulder rash.Follow-up investigation: patient had a (b)(6) 2013 rotator cuff repair and biceps tenodesis of the right shoulder.On (b)(6) 2014 patient had a rotator cuff repair due to worsening pain and decreasing range of motion in the right shoulder.This was performed by another surgeon at another facility.Surgeon used non-bioabsorbable suture anchors.Approximately 3 weeks after the (b)(6) 2014 surgery patient developed a raised, annular, red rash on the surgical arm and shoulder area.Patient has no known contact issues or drug allergies.The orthopedic surgeon prescribed antibiotics and topical steroid medications with no improvement.On (b)(6) 2014 patient underwent a shoulder arthroscopic exploration due to worsening pain and loss of shoulder mobility following the prior, (b)(6) 2014, rotator cuff repair.Findings during the (b)(6) 2014 surgery were consistent with: recurrent rotator cuff tear, osteolysis, chondral damage, synovitis and particulate debris.There was evidence of degradation of one of the plla arthrex anchors from the (b)(6) 2013 surgery.This anchor was removed as it was partially extruding from the bone and was producing debris in the joint.Approximately 3 weeks after the (b)(6) 2014 surgery patient developed a very similar red, raised annular rash on the surgical arm and shoulder area.The orthopedic surgeon prescribed antibiotics and topical steroid medication with no improvement.The rash worsened and spread to a larger surface area of the surgical arm and shoulder.Patient was referred to a dermatologist who biopsied the area.Findings were suggestive of a foreign body reaction.The biopsy was not consistent with a drug reaction.The rash has been relapsing and remitting, coinciding with continuing shoulder pain.

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 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.Based on the information provided, the most likely cause(s) of this event is an adverse reaction of the patient to the material(s) implanted.Product directions for use warns of adverse effects like foreign body and allergic-like reactions as well as infections both deep and superficial to the implant materials.Patient sensitivity to device materials must be considered prior to implantation.This is the first complaint of this type for this part/lot combination.If additional relevant information is received, a follow-up report will be submitted.Part remained in patient.

• Brand Name: SUTURE ANCH BIOCOMP SWI- VELOCK C CLD 4.75X19.1MM
• 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: 4869029
• MDR Text Key: 21081290
• Report Number: 1220246-2015-00168
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101823
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/05/2015

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: 11/01/2014
• Device Catalogue Number: AR-2324BCC
• Device Lot Number: 569224
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/05/2015
• Initial Date FDA Received: 06/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2012
• 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
• Treatment: AR-1670BC, TENODESIS SCREW, LOT 534635.
• Patient Outcome(s): Other