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 Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 1/31/2024, it was reported by a sales representative via email that the suturetape from an ar-8934bcst single loaded suturetape s-tak assy pulled out of the anchor, and the anchor remained in the bone.This was discovered during a kidner procedure.Nothing broke inside the patient, and the case was completed successfully.The case was not delayed, and additional anesthesia was not needed.The patient suffered no negative effects on or after the procedure.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.On 1/31/2024, it was reported by a sales representative via email that the suturetape from an ar-8934bcst single loaded suturetape s-tak assy pulled out of the anchor, and the anchor remained in the bone.This was discovered during a kidner procedure.Nothing broke inside the patient, and the case was completed successfully.The case was not delayed, and additional anesthesia was not needed.The patient suffered no negative effects on or after the procedure.

• 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: 18768688
• Report Number: 1220246-2024-01090
• Device Sequence Number: 4500202
• Product Code: HWC
• UDI-Device Identifier: 00888867375116
• UDI-Public: 00888867375116
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 06/04/2025

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: 02/28/2025
• Device Model Number: 3.0 SINGLE LOADED SUTURETAPE S-TAK ASSY
• Device Catalogue Number: AR-8934BCST
• Device Lot Number: 12873798
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/23/2024
• Supplement Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2021
• 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
• Patient Sex: Unknown