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

Model Number	SUTURE ANCHOR, MINI CORKSCREW FT
Health Effect - Clinical Codes	Pain (1994); Joint Swelling (2356)
Date of Event	08/02/2018
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 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 that the patient underwent a radial collateral ligament repair on her right thumb on (b)(6) 2017 where an arthrex titanium anchor (part number unknown) was implanted.She reported that she is now experiencing persistent pain and swelling in the joint, even at rest.The patient will be seeing an allergist to see if she has an allergy to titanium.Additional information requested.Additional information obtained 8/24/2018: patient has provided the part number of the anchor.It was an ar-1319ft, suture anchor, mini corkscrew ft.The lot number provided by the patient (lot 10133878) is not a valid lot number for this device.

• Brand Name: SUTURE ANCHOR, MINI CORKSCREW FT
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7860866
• Report Number: 1220246-2018-00630
• Device Sequence Number: 1986873
• Product Code: HWC
• UDI-Device Identifier: 00888867008533
• UDI-Public: 00888867008533
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K112237
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/10/2018

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: SUTURE ANCHOR, MINI CORKSCREW FT
• Device Catalogue Number: AR-1319FT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2018
• Initial Report FDA Received Date: 09/10/2018
• 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