MAUDE Adverse Event Report: ARTHREX, INC. BC ACHILLES SPDBRG W/ KL DX CC, 3.9 MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	BC ACHILLES SPDBRG W/ KL DX CC, 3.9 MM
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/20/2024
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 3/20/2024, it was reported by a sales representative via email that the solider repair stitch of one of the fibertak from an ar-9928bck-dx biocomposite achilles speedbridge implant system pulled out of the anchor.The surgeon inserted the proximolateral knotless fibertak, and when the solid repair stitch was pulled, the stitch pulled out of the anchor along with the knotless mechanism.The case was completed using the existing anchor¿s tapes and making a traditional speedbridge.The knotless ripstop was not completed because there was no repair stitch or knotless mechanism in the faulty anchor after it pulled out.The case was delayed about five minutes.This was discovered during an achilles speedbridge procedure on (b)(6) 2024.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.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 can be attributed to misaligned insertion; or prying/leveraging the device during use.

• Brand Name: BC ACHILLES SPDBRG W/ KL DX CC, 3.9 MM
• 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: 19096771
• Report Number: 1220246-2024-02004
• Device Sequence Number: 18107462
• Product Code: HWC
• UDI-Device Identifier: 00888867425736
• UDI-Public: 00888867425736
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K201749
• 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): 06/10/2025

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 Model Number: BC ACHILLES SPDBRG W/ KL DX CC, 3.9 MM
• Device Catalogue Number: AR-9928BCK-DX
• Device Lot Number: 15137721
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2024
• Supplement Date Received by Manufacturer: 05/17/2025
• Initial Report FDA Received Date: 04/12/2024
• Supplement Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/05/2023
• 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