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

Model Number	MIS 3.9MM BC ACHILLES SPDBRG W/ KL DX CC
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 03/24/2025, it was reported by a sales representative via email that an ar-9928bck-mis mis fibertak achilles speedbridge had the cannulated 2.6 drill bit break off inside of the patient when drilling for the mis achilles speedbridge procedure on (b)(6) 2025.The first drill hole worked smoothly and it was observed the patient had hard bone.The surgeon went to drill for the second drill hole, and the drill bit broke halfway when drilling down to the positive stop.The surgeon was able to remove the broken piece from the patient and they were able to complete the surgery successfully.This was discovered during use.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
Additional information: b5, h3, h6.
Event or Problem Description
Additional information was received on 04/14/2025: the case was delayed 10 minutes as the surgeon had to remove the broken drill bit from the patient.No additional anesthesia was administered to the patient.The case was completed using a solid 2.6 drill since the cannulated 2.6 drill broke.No adverse effects or significant damage was reported on or after the surgery on the patient.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.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 the most likely cause.The most likely cause of the reported failure is user error, including excessive force, misaligned insertion, and/or prying or levering the device during insertion, which resulted in the device breaking.The complaint allegation was confirmed based on the customer's attached picture were the drill is displayed broken next to a bent guide wire.

• Brand Name: MIS 3.9MM BC ACHILLES SPDBRG W/ KL DX 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: 21859070
• Report Number: 1220246-2025-01536
• Device Sequence Number: 15433001
• Product Code: HWC
• UDI-Device Identifier: 00888867389533
• UDI-Public: (01)00888867389533(11)241212(17)281031(10)15361097
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 09/26/2025

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: MIS 3.9MM BC ACHILLES SPDBRG W/ KL DX CC
• Device Catalogue Number: AR-9928BCK-MIS
• Device Lot Number: 15361097
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/24/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2025
• Supplement Date Received by Manufacturer: Not provided; 09/25/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 04/29/2025; 09/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown