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

Model Number	SUTR ANCH,CRKSCRW
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	02/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that a patient was treated with two ar-1920snf to refixate the achilles tendon in the calcaneus after removal of the haglund exostosis.After the surgery the patient has complaints due to irritation and swelling in this area.It was further reported that this has already been revised in a second surgery and the symptoms are still present.The customer is unsure where the problem is coming from but assumes it could be the fiberwire is causing the reaction.No further information received.***update dw 06-sep-2024: further information was provided that the initial surgery was performed on 01-jun-2023 and the revision surgery was performed on (b)(6) 2024.It was further reported that not all parts of the implant could be removed.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation is not confirmed.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.Patient sensitivity to device materials must be considered prior to implantation.Per dfu-0087-eo c contraindications 2.Blood supply limitations and previous infections, which may retard healing.3.Foreign body sensitivity.Where material sensitivity is suspected, appropriate tests should be made and sensitivity ruled out prior to implantation.5.Any active infection or blood supply limitations.J.Material specifications suture (if supplied): see package label for size and type of suture provided with device.The fiberwire, fiberwire cl, tigerwire®, tigerwire cl, fibertape, and tigertape¿ sutures are made of ultra high molecular weight polyethylene (uhmwpe) and polyester.The fiberwire and tigerwire sutures include fiberstick¿, tigerstick®, fiberchain®, fiberlink¿, tigerlink¿, tigertail®, fiberloop® and tigerloop¿ sutures.The fiberlink, tigerlink, fiberloop and tigerloop sutures may also be braided from suturetape sutures.Additional materials may include silicone elastomer coating (except suture with the suffix -tape), cyanoacrylate, and may include nylon.Suturetape is made from ultra high molecular weight polyethylene (uhmwpe) and polyester.Additional materials may include nylon and/or cyanoacrylate.The #2 suture, and #5 suture are a polyblend made from ultra high molecular weight polyethylene (uhmwpe) and polyester.Additional materials may include nylon and/or cyanoacrylate.The sutures supplied meet or exceed u.S.And european pharmacopeia standards for non-absorbable surgical sutures (except for diameter requirements).The suture dyes may include: d&c blue no.6, d&c green no.6, logwood black, fd&c blue no.2, d&c black no 4 and chromium cobalt aluminum oxide.Suture strands that are dyed with logwood black are made of nylon.Other non-absorbable suture is made from polyester, polytetrafluoroethylene (ptfe) coating, and cyanoacrylate.K.Storage conditions: bioabsorbable devices must be stored in the original unopened packaging in a dry place at maxi k.Storage conditions bioabsorbable devices must be stored in the original unopened packaging in a dry place at maximum 32° c / 90° f, and should not be used after the expiration date.Non-bioabsorbable devices must be stored in the original unopened packaging, away from moisture and should not be used after the expiration date.The most likely cause for the reported failure can be attributed to a patient-specific event.

• Brand Name: SUTR ANCH,CRKSCRW
• Common Device Name: BONE FIXATION SCREW/PLATE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 20213200
• Report Number: 1220246-2024-07602
• Device Sequence Number: 7494702
• Product Code: HWC
• UDI-Device Identifier: 00888867022843
• UDI-Public: 00888867022843
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K061863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2025

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: 09/30/2023
• Device Model Number: SUTR ANCH,CRKSCRW
• Device Catalogue Number: AR-1920SNF
• Device Lot Number: 10243339
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2024
• Supplement Date Received by Manufacturer: 02/26/2025
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown