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

Model Number	SUTURE ANCHOR, PEEK CORKSCREW FT
Health Effect - Clinical Codes	Erythema (1840); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Pain (1994)
Date of Event	09/07/2018
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 explanted device was reported to have been discarded.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
An initial contact was received through the arthrex website requesting a contact person regarding post-operative infections involving arthrex products.Upon further investigation it has been discovered that a patient had left shoulder arthroscopy-rotator cuff repair procedure on (b)(6) 2018.During the procedure the following arthrex products were implanted: arthrex suture anchor peek corkscrew ft 4.5x14mm x2(ar-1927psf-45, lot: f200079 and lot: f185845) and suture anchor pushlock 3.5x19.5mm x3(ar-1926ps, lot: 10194738).During patient office visit on (b)(6) 2018 patient reported possible reaction type symptoms.The symptoms included: erythema, pain and tenderness.The patient has been treated with po antibiotics, and surgery to drain shoulder and remove all implants except for two pushlock anchors.Testing has been performed however to date all cultures have been reported as negative, including p-acnes.Additional information obtained 9/11/2018: the date of the second surgery to drain shoulder and remove all implants except for two pushlock anchors was (b)(6) 2018.The surgery was performed at a different facility than the original procedure.The explanted anchors are reported to have been discarded.

• Brand Name: SUTURE ANCHOR, PEEK CORKSCREW FT
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7902474
• Report Number: 1220246-2018-00667
• Device Sequence Number: 19191978
• Product Code: HWC
• UDI-Device Identifier: 00888867023666
• UDI-Public: 00888867023666
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K061863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/24/2018

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 Expiration Date: 02/28/2023
• Device Model Number: SUTURE ANCHOR, PEEK CORKSCREW FT
• Device Catalogue Number: AR-1927PSF-45
• Device Lot Number: F200079
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2018
• Initial Report FDA Received Date: 09/24/2018
• 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