MAUDE Adverse Event Report: ARTHREX, INC. SWIVELLOCK TENODESIS BIO-COMPOSITE 7 X 19.5 MM; SCREW, FIXATION, BONE

Catalog Number	AR-1662BC-7
Health Effect - Clinical Codes	Respiratory Distress (2045); Swelling (2091)
Date of Event	04/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, gender, 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 not returned for evaluation but remained in the patient 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.A possible cause of this type of event may be a reaction of the patient to the material(s) implanted or used during the implant procedure.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 materials must be considered prior to implantation.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.This is one of five submissions for the same patient event.The others are 1220246-2017-00232 ((b)(4)), 1220246-2017-00233 ((b)(4)), 1220246-2017-00234 ((b)(4)) and 1220246-2017-00235 ((b)(4)).Device remains in patient.
Event or Problem Description
It was reported that the patient underwent a rotator cuff repair on (b)(6) 2017 where a bio-composite swivelock tenodesis suture anchor, ar-1662bc-7 ((b)(4)) was implanted into the patient's shoulder.Approximately four days after the surgery, the patient began to experience trouble breathing and swelling in the throat.The patient has been treated at the er for symptoms.No redness or swelling can be seen at the surgery site.The patient claims they have never had any issues of this nature until after their procedure.The patient's only known allergy is penicillin.The below part numbers were also implanted on (b)(6).Ar-1662bc lot 10110092 1 ea ((b)(4)), ar-1927psf lot 10068319 1 ea ((b)(4)), ar-1926ps lot 10064848 1 ea ((b)(4)) and ar-1926ps lot 10053400 1 ea ((b)(4)).

• Brand Name: SWIVELLOCK TENODESIS BIO-COMPOSITE 7 X 19.5 MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6671329
• Report Number: 1220246-2017-00221
• Device Sequence Number: 11005288
• Product Code: HWC
• UDI-Device Identifier: 00888867020573
• UDI-Public: 00888867020573
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 06/27/2017

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: Health Professional
• Device Catalogue Number: AR-1662BC-7
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2017
• Initial Report FDA Received Date: 06/27/2017
• 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