MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMPOSITE SWIVELOCK; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	AR-2324BCM
Health Effect - Clinical Codes	Dehydration (1807); Dyspnea (1816); Erythema (1840); Fatigue (1849); Inflammation (1932); Itching Sensation (1943); Impaired Healing (2378); Reaction (2414)
Date of Event	12/06/2011
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, weight) were requested but not provided.This is the first of two submissions from the same patient event.The other is 1220246-2016-00433 ((b)(4)).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.No device malfunction identified.At this time, it cannot be determined if the device may have caused or contributed to the patient's experience.An evaluation of the device cannot be performed as the device was not returned to arthrex.Device history record review revealed nothing relevant to this event.Additional information has been requested but not made available.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.The most likely cause of this type of event is a reaction of the patient to the material(s) implanted.Product directions for use warns of 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.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 remains in patient.
Event or Problem Description
It was reported by patient that she underwent a right rotator cuff repair on (b)(6) 2011.Patient was inquiring the material composition of her implants.Specific implant part numbers were not known.Patient was directed to contact the procedure facility to request the implant log to obtain specific part numbers.Additional information obtained (b)(6) 2016: patient provided part numbers of the implants for which she needs material composition: (b)(4) ((b)(4)) and (b)(4) ((b)(4)).Material composition has been provided to the patient.Additional information obtained (b)(6) 2016: patient states she has been having a reaction in the healing process such that the incision area has never healed and has stayed red with inflammation and at times itchy.In (b)(6) 2013 patient went to er for difficulty breathing.Since that time patient has dealt with a multitude of issues and has been seen by many specialist at several facilities.Patient states retention of too much carbon dioxide, fast paced breathing pattern, body in state of dehydration despite adequate water intake and using salt, electrolytes and hyaluronic acid, fatigue and increased issue breathing due to gasping and globus with physical activity, fluctuating balance and inability to drive.Patient states that it appears that whatever is causing her issue has also activated tick borne related illness of bartonella.Patient has received various treatments over the years but issues have not dissipated.

• Brand Name: BIO-COMPOSITE SWIVELOCK
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 5995147
• Report Number: 1220246-2016-00434
• Device Sequence Number: 698414
• Product Code: MAI
• UDI-Device Identifier: 00888867026865
• UDI-Public: 00888867026865
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 09/02/2016

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/01/2013
• Device Catalogue Number: AR-2324BCM
• Device Lot Number: 470112
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2016
• Initial Report FDA Received Date: 10/03/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other