MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCHBIO-COMP S-TAK KNOTLESS; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	SUTR ANCHBIO-COMP S-TAK KNOTLESS
Health Effect - Clinical Codes	Pain (1994); Burning Sensation (2146); Numbness (2415); Ambulation or Postural Difficulties (2544); Weight Changes (2607)
Date of Event	04/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation therefore the complainant's event could not be verified.The device remains in the patient.The cause of the event could not be determined from the information available and without device evaluation.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.
Event or Problem Description
It was reported by a patient that she had undergone hip surgery (b)(6) 2018 during which arthrex products were implanted.Almost immediately after the surgery the patient began having a severe burning sensation in her body which has not gone away.At time of report patient did not have part numbers or any additional information which has been requested.During the (b)(6) 2018 procedure an (b)(4), knotless suture anchor bio-composite s-tak, was implanted.Patients symptoms range over her entire body however the surgical site hurts more and experiences the symptoms more than the other parts of her body.Symptoms include: sweating continually, especially at night, pain at the surgical site, knees gets so bad sometimes she cannot move her knee - sometimes having periods of hours where she cannot walk until the pain has passed, burning sensation throughout her entire body, face becomes red to the point of appearing as if she has an allergy or rash, her feet get numb from her knee to where she had surgery - losing feeling as if the nerve has gone numb and she has lost a lot of weight.Patient has no known allergies.Patient has had bloodwork which was negative and patient has provided bloodwork to arthrex.To date patient has been prescribed meloxicam and diclofenac as well as 2 months of physical therapy which did not help.Patient also provided fluoroscopy pictures from surgery to arthrex.Patient will be provided with the material composition of the (b)(4).

• Brand Name: SUTR ANCHBIO-COMP S-TAK KNOTLESS
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7942977
• Report Number: 1220246-2018-00690
• Device Sequence Number: 13685760
• Product Code: MAI
• UDI-Device Identifier: 00888867097186
• UDI-Public: 00888867097186
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K180594
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/08/2018

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 Model Number: SUTR ANCHBIO-COMP S-TAK KNOTLESS
• Device Catalogue Number: AR-1938BC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2018
• Initial Report FDA Received Date: 10/08/2018
• 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