MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, BIO-COMP. SUTURETAK; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	AR-1934BCF
Health Effect - Clinical Codes	Rash (2033); Swelling (2091); Burning Sensation (2146); Reaction (2414); Alteration In Body Temperature (2682)
Date of Event	08/04/2016
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 four submissions from the same patient event.The others are 1220246-2016-00359 ((b)(4)), 1220246-2016-00361 ((b)(4)) and 1220246-00362 ((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.Device history record review revealed nothing relevant to this event.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.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 the patient on day of the revision procedure, (b)(6) 2016,that she had undergone an acl reconstruction on (b)(6) 2016 on her right leg.On (b)(6) 2016 the patient began to notice extreme swelling, knee was hot to the touch, she had a skin rash with welts and burning in and around the incision.The reaction also spread to the lateral side of the femur and tibia.The patient had an er visit on (b)(6) 2016 where bloodwork was taken.Results were negative for infection.Surgeon decided to bring patient in for second surgery and possible removal of the implants.Patient states that prior to the (b)(6) 2016, procedure she had allergy testing which showed that she was allergic to nickel.The following parts were implanted during the original (b)(6) 2016 procedure: ar-1934bcf lot 1240957 ((b)(4)), ar-1934bcf lot 1240946 ((b)(4)), ar-2324bcc lot 10025466 ((b)(4)) and ar-5035tc-09 lot 1314851 ((b)(4)).On 8/12/2016 the surgeon reported that during the (b)(6) 2016 second surgery, no arthrex products were explanted.The surgeon performed a synovectomy with irrigation & debridement.Surgeon stated that the repair looked good.Surgeon states that the patient symptoms appeared to be more like an infection, possibly a low grade cellulitis.Patient was treated with iv antibiotics and was put on a 1-2 week regimen of oral antibiotics.

• Brand Name: SUTURE ANCHOR, BIO-COMP. SUTURETAK
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 5897902
• Report Number: 1220246-2016-00360
• Device Sequence Number: 521296
• Product Code: MAI
• UDI-Device Identifier: 00888867023871
• UDI-Public: 00888867023871
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K110660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 08/04/2016

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 Expiration Date: 10/01/2016
• Device Catalogue Number: AR-1934BCF
• Device Lot Number: 124096
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2016
• Initial Report FDA Received Date: 08/23/2016
• 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