MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, CORKSCREW FT II; SCREW, FIXATION, BONE

Catalog Number	AR-1928SF-2
Health Effect - Clinical Codes	Rash (2033); Test Result (2695)
Date of Event	04/26/2016
Type of Reportable Event	Serious Injury
Additional 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.This is the first of two submissions for the same patient event.The other is 1220246-2016-00574 ((b)(4)).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 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.If additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
It was reported by a patient's mother that the ar-1928sf-2, corkscrew ft ii suture anchor ((b)(4)), along with the ar-1928sf-3,corkscrew ft iii suture anchor ((b)(4)), were being used in a left rotator cuff and biceps triceps repair procedure.The procedure was completed successfully.The patient started noticing a red rash at the surgery site the day after the procedure.The surgeon recommended the patient go see a dermatologist.The dermatologist prescribed prednisone, and recommended the patient to go to an allergist.Patient was tested for h.Pylori and came back negative.No metal allergy tests happened at this time.Finally went to the hospital and had a heavy metal panel done for arsenic, mercury, and lead, and that test came back negative.To date, patient still has a rash at the surgical site and also has fluid and blood coming from his ears.Reporter has been instructed that since the patient is an adult for hippa purposes any further contact would need to be directly with the patient.Arthrex has requested the contact information for the patient.As of 12/13/2016 the contact information has not been provided.Patient: male, (b)(6).

• Brand Name: SUTURE ANCHOR, CORKSCREW FT II
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6173239
• Report Number: 1220246-2016-00573
• Device Sequence Number: 865573
• Product Code: HWC
• UDI-Device Identifier: 00888867023703
• UDI-Public: 00888867023703
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K061863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date (Section B): 12/14/2016

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: Health Professional
• Device Catalogue Number: AR-1928SF-2
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2016
• Initial Report FDA Received Date: 12/14/2016
• 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
• Patient Age: 46 YR