MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH,CRKSCRW FT; SCREW, FIXATION, BONE

Model Number	SUTR ANCH,CRKSCRW FT
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	05/13/2020
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.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
During (b)(6) 2019 a patient had reported having possible reaction issues to arthrex ar-1928snf, corkscrew suture anchors that had been implanted (b)(6) 2016.The prior report has been recorded in the arthrex system under reference: case (b)(4) and was reported to the fda (1220246-2019-01534) on 12/26/2019.The patient has notified arthex that she was later referred to the mayo clinic where she underwent surgery on (b)(6) 2020 during which the new surgeons removed the two arthrex implants and also repaired an abductor tendon tear.The implants were given to the patient.The patient is currently recovering from the surgery and is hopeful that she will be able to resume walking and that the pain will continue to decline.

• Brand Name: SUTR ANCH,CRKSCRW FT
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10217671
• Report Number: 1220246-2020-01932
• Device Sequence Number: 2120934
• Product Code: HWC
• UDI-Device Identifier: 10888867023779
• UDI-Public: 10888867023779
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K061863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/01/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: SUTR ANCH,CRKSCRW FT
• Device Catalogue Number: AR-1928SNF
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2020
• Initial Report FDA Received Date: 07/01/2020
• 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