MAUDE Adverse Event Report: ARTHREX, INC. 3.0 SINGLE LOADED SUTURETAPE S-TAK ASSY; BIO SOFT TISSUE FIXATN FASTNR

Model Number	3.0 SINGLE LOADED SUTURETAPE S-TAK ASSY
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2024
Type of Reportable Event	Malfunction
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On 01/23/2024, it was reported by a sales representative via email that an ar-8934bcst 3.0 single loaded suturetape and an ar-8934dsc small joint suturetak disposable instruments kit had an issue.The surgeon prepped the cortical bone with a bovie and a burr first.He proceeded to drill with a 3.2mm drill and implanted two 3.5mm panalock anchors for a biceps tenodesis.He wanted an 3rd anchor and the account did not have any more remaining, so he requested to use a 3.0 suturetak with needles.He used a 2.5 drill from the kit and cycled the drill, when he went to put the anchor in, it plugged all the way down and he was able to pull out the anchor without any resistance.He chose not to size up to a larger anchor and believed the repair with the other two anchors to be sufficient.This was discovered during a biceps tenodesis procedure.The subsequent implant did not deploy.No patient was harmed.
Additional Manufacturer Narrative
Additional information: b5, g3, h3, h6.Based on the information provided, which may include the device (if available and returned), pictures, videos, event descriptions, and any additional information from the field, arthrex concluded that the most likely cause of the reported failure is user error, specifically improper bone preparation and/or improper surgical technique with the device.The complaint allegation was confirmed based on the customer's attached picture, which shows the anchor on the shaft of the ar-8934bcst.
Event or Problem Description
Additional information reconceived on 2/8/2024: the case was not delayed, and no additional anesthesia was needed.The patient suffered no negative effects.

• Brand Name: 3.0 SINGLE LOADED SUTURETAPE S-TAK ASSY
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• 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: 18702778
• Report Number: 1220246-2024-00955
• Device Sequence Number: 7395633
• 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
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2026
• Device Model Number: 3.0 SINGLE LOADED SUTURETAPE S-TAK ASSY
• Device Catalogue Number: AR-8934BCST
• Device Lot Number: 14930814
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2024
• Supplement Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 02/14/2024
• Supplement Report FDA Received Date: 06/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2022
• 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
• Patient Sex: Unknown