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	Defective Device (2588)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 3/8/2024, it was reported by a sales representative via phone that an ar-9928bck-dx achilles speedbridge repair implant system had an issue during an achilles repair procedure on (b)(6) 2024.The fibertak in that system should only have one loop per anchor, but one of the two fibertak devices had two loops instead and could not be used.This was discovered upon insertion into the patient, and the technique could not be done correctly due to the double-looped suture.The sutures of the complaint device were then cut and removed, and the anchor remained inside the patient.Nothing broke inside the patient.The ripstop of the procedure was eliminated.The other fibertak was used without any issues.Both anchors were left inside the patient, and the speed bridge part of the procedure was completed, but not the ripstop part.The achilles repair procedure was still completed successfully, but not according to the technique guide.The surgeon deemed everything to be affixed correctly, and there was no harm or adverse effect on the patient.A case delay of 90 minutes was reported, and it could not be confirmed whether additional anesthesia was administered to the patient.No pictures or videos were taken, and the device was unavailable for return.This occurred during use with no patient harm.
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.
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 descriptions, and any additional information from the field, arthrex concluded that the most likely cause of the reported failure is an internal manufacturing process issue.The complaint allegation was not confirmed as the device was not received for evaluation, and no evidence of the failure was provided.

• 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: 18980996
• Report Number: 1220246-2024-01659
• Device Sequence Number: 6298982
• Product Code: HWC
• UDI-Device Identifier: 00888867425736
• UDI-Public: 00888867425736
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 06/09/2025

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: 15155365
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2024
• Supplement Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 03/26/2024
• Supplement Report FDA Received Date: 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2023
• 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