MAUDE Adverse Event Report: ARTHREX, INC. LARGE PEC BUTTON; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number AR-2267

Device Problem Insufficient Information (3190)

Patient Problems Purulent Discharge (1812); Unspecified Infection (1930); Swelling (2091); Discomfort (2330)

Event Date 06/21/2016

Event Type  Injury  

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.This is one of two submissions from the same event, the other is (b)(4).The device was requested for evaluation but remained in the patient, therefore the complainant's event could not be verified.Device history record review revealed nothing relevant to this event; no issues were found with the sterilization of this lot.This device is supplied sterile.Based on the information provided, a definitive cause for the post-operative infection could not be determined.The most likely cause for this type of event is a nosocomial source or patient non-compliance with post-op wound care directions.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.

Event Description

It was reported that patient underwent a left open pectoralis major tendon primary repair on (b)(6) 2015.A second surgery was performed on (b)(6) 2016 due to reaction symptoms, no products explanted.Procedure culture results negative.Post-op (b)(6) 2016 surgery, patient reported a bump and increased drainage from a region in the upper arm.He initially saw a dermatologist who performed a local biopsy, which also showed negative/no growth.Shortly after biopsy bump area began leaking pus/blood with granulated tissue.An urgent care facility administered iv (clindamycin and prescribed oral clindamycin).Surgeon instructed patient to follow the oral antibiotic regimen and put pressure on the affected area 4 times daily to drain the pus as much as possible.On (b)(6) 2016 patient saw his original surgeon.Patient's medical records noted patient has a draining sinus tract, expressing some thick drainage, although no foul-smelling fluid was encountered.Records noted no constitutional symptoms (fevers, shakes or chills), incision appeared intact with patient having some discomfort about the upper extremity, which was noted to have been improving with drainage from the region.Examination noted there was an approximately 2-3 cm lateral and 2 cm inferior to the axillary fold area of exposed granulation tissue through which some slightly thick scan drainage appreciated.Patient was prescribed to continue the clindamycin regimen with an added prescription for augmentin and patient was scheduled for a third surgery which was performed on (b)(6) 2016.During the procedure three sutures (one #5 fiberwire and two fibertape sutures) were explanted in their entirety along with the sinus tract and granulomatous tissue in its entirety.Op report notes no evidence of appearance of necrotic tissue identified.Op report noted that proximally the pectoralis major tendon was completely intact and that there was re-attachment of the pectoralis major tendon back on to the humeral shaft.It was noted that surgeon encountered some soupy type tissue and scant drainage was appreciated, just underneath deep to the repair site itself.It was noted this most likely communicated inferiorly with the sinus tract.Deep wound cultures were taken.A 0.25 inch penrose drain was placed.The pec buttons originally implanted (b)(6) 2015 in the humeral shaft were not encountered.Surgeon noted in patient medical records that the button is most likely within the intramedullary canal of the humerus and surgeon felt there was no reason to attempt removal.This was explained to the patient at the (b)(6) 2016 post op follow up.Patient was to continue with a regimen of augmentin, coupled with clindamycin, which may be necessary for a few months.06/24/16 follow up visit medical records noted patient had decreased discomfort and soreness compared to first post of follow up.No fluctuance was noted about the shoulder region.Residual serosanguinous type drainage from the drain was noted to have substantially decreased.The penrose drain was removed.Culture results dated (b)(6) 2016 from the (b)(6) 2016 surgery were positive for scant growth staphylococcus coagulase negative (a) and scant growth finegoldia magna (a).Patient himself has reported on 7/18/2016 that pain/discomfort in his left arm seems to now have resolved although his left arm still feels somewhat different or heavier than his right.Patient's antibiotic treatment was a 6 week regimen of which he reports being 3 weeks into.Patient further reported that two separate infectious disease specialists he consulted have advised that if the 6 weeks of antibiotics does not resolve the issue the pec buttons will need to be explanted.

• Brand Name: LARGE PEC BUTTON
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, 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: 5867958
• MDR Text Key: 51818632
• Report Number: 1220246-2016-00332
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00888867026544
• UDI-Public: 00888867026544
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123341
• 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: 07/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2020
• Device Catalogue Number: AR-2267
• Device Lot Number: 500008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2015
• 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