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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 03/20/2025, it was reported by a sales representative via phone that an ar-9928bck-dx achilles speedbridge fibertape was not swedged together and a swivellock eyelet and sutures came out when inserted.This occurred during use in a case with no patient effect.Case was completed using another swivellock.Delay in case was 30 minutes.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation is not confirmed.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 a manufacturing issue; however, due to the device not being returned, we are unable to confirm the reported event.

• 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: 21859733
• Report Number: 1220246-2025-01540
• Device Sequence Number: 14632577
• Product Code: HWC
• UDI-Device Identifier: 00888867425736
• UDI-Public: (01)00888867425736(11)250224(17)281231(10)15394247
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 09/15/2025

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: 15394247
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2025
• Supplement Date Received by Manufacturer: 09/04/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown