MAUDE Adverse Event Report: ARTHREX, INC. 3.9MM BC ACHILLES PARS/ AMSS CC; BIO SOFT TISSUE FIXATN FASTNR

Model Number	3.9MM BC ACHILLES PARS/ AMSS CC
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 12/5/2024, an fda medwatch notification was received via email.A facility representative reported that the tip of the drill bit from an ar-9929bc-cp biocomposite achilles pars kit broke off into a few pieces inside the patient's heelbone.The surgeon extracted the pieces manually using the available surgical instruments.This was discovered during a procedure on (b)(6) 2024.Additional information received on 12/12/2024: during the drilling process on the lateral aspect of the calcaneus, the drill bit broke.The k wire was removed, and all portions of the drill bit were removed, with confirmation on intraoperative fluoroscopy.This was discovered during an achilles tendon repair with arthrex pars with a suture bridge.
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: 3.9MM BC ACHILLES PARS/ AMSS CC
• 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: 21061306
• Report Number: 1220246-2025-09181
• Device Sequence Number: 18332341
• Product Code: HWC
• UDI-Device Identifier: 00888867389564
• UDI-Public: (01)00888867389564(11)240911(17)280731(10)15315565
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K201749
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2025

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: 3.9MM BC ACHILLES PARS/ AMSS CC
• Device Catalogue Number: AR-9929BC-CP
• Device Lot Number: 15315565
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2024
• Supplement Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 01/02/2025
• Supplement Report FDA Received Date: 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2025
• 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