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 Codes	Break (1069); Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 12/06/2024, a sales representative via (b)(4) reported that an ar-9928bck-dx bc achilles spdbrg w/ kl dx cc had an issue during use.While threading the anchor into the bone, the anchor cracked on one side, and simultaneously, the driver broke off during use.The cracked anchor caused the driver to thread the anchor further into the bone before the driver itself broke.They retrieved the broken driver from the surgical site without difficulty.A second bc achilles spdbrg was used to successfully complete the procedure as planned.There was no adverse impact on the patient due to the issue.This was discovered during a procedure on (b)(6) 2024, with no reported patient harm.Additional information has been requested.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
Additional information was received on 01/02/2025: the cracked anchor was retrieved and then re-inserted into the patient.However, the anchor was slightly damaged and had to be trimmed off by a few millimeters at the top layer of the bone to ensure it was flush.The anchor was flush at the end of the repair.No revision surgery was needed, and no case delay was reported.No adverse effects on the patient were reported.This was discovered during a haglunds bone spur removal and achilles repair 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 for the reported failure can be attributed to user error of the device due to excessive force being used during insertion of the implant.

• 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: 21070738
• Report Number: 1220246-2025-09199
• Device Sequence Number: 8399175
• Product Code: HWC
• UDI-Device Identifier: 00888867425736
• UDI-Public: (01)00888867425736(11)240911(17)280731(10)15315608
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Followup
• Report Date (Section B): 07/10/2025

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: 15315608
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2024
• Supplement Date Received by Manufacturer: 01/02/2025; 06/13/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 01/28/2025; 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2024
• 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