MAUDE Adverse Event Report: ARTHREX, INC. 3.0 SINGLE LOADED SUTURETAPE S-TAK ASSY; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	3.0 SINGLE LOADED SUTURETAPE S-TAK ASSY
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	05/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event has not yet been determined as the device has not been returned for evaluation at this time.A follow-up report will be submitted, including a most likely cause if a root cause can not be determined.
Event or Problem Description
On (b)(6) 2023, it was reported by a relative of a patient, via phone, that the patient is experiencing a reaction 3 weeks after undergoing a right de rotational femoral osteotomy with allograft and mpsl reconstruction with allograft on (b)(6) 2023 in which (2) ar-8934bcst suture tapes, an ar-8719mxds-2015 dynanite staple, and an ar-4030p-07 peek interference screw were implanted.The patient was admitted to the hospital after experiencing a breakout of hives.The patient is being treated with steroids and other antihistamines that are keeping her stable.The patient is awaiting allergy testing.There was no additional information provided additional information was requested.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 the complaint allegation is not confirmed based on the documents submitted for evaluation.Consequently, 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.The most likely cause for the reported failure can be attributed to a patient-specific event.

• Brand Name: 3.0 SINGLE LOADED SUTURETAPE S-TAK ASSY
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• 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: emily shafer ; 8009337001
• MDR Report Key: 17377040
• Report Number: 1220246-2023-07261
• Device Sequence Number: 6638839
• Product Code: HWC
• UDI-Device Identifier: 00888867375116
• UDI-Public: 00888867375116
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K082810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2025

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: 03/31/2025
• Device Model Number: 3.0 SINGLE LOADED SUTURETAPE S-TAK ASSY
• Device Catalogue Number: AR-8934BCST
• Device Lot Number: 13155996
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2023
• Supplement Date Received by Manufacturer: 01/31/2025
• Initial Report FDA Received Date: 07/24/2023
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/20/2021
• 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