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	Foreign Body In Patient (2687)
Date of Event	02/07/2025
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 02/07/2025, it was reported by a sales representative via phone ar-9928bck-mis achilles speedbridge broke.This occurred during an mis achilles procedure on (b)(6) 2025 when the cannulated drill bit broke inside the patient's calc.The fragments were unable to be retrieved.The procedure was completed using an ar-8929bc-cp.There was a delay of about 10 minutes and it is uncertain if additional anesthesia was administered.
Additional Manufacturer Narrative
Additional information: g3, h3, h6, h11.The complaint allegation is confirmed.Photographic evidence provided from the field of an unpackaged ar-9928bck-mis, with batch number 15222869, revealed a damaged distal tip.Therefore, arthrex was able to deduce a most likely cause.The most likely cause is attributed to misuse due to prying/leveraging the device during use.

• 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: 21433403
• Report Number: 1220246-2025-00591
• Device Sequence Number: 17294311
• Product Code: HWC
• UDI-Device Identifier: 00888867389533
• UDI-Public: (01)00888867389533(11)240320(17)280131(10)15222869
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 08/25/2025

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: 15222869
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2025
• Supplement Date Received by Manufacturer: 08/24/2025
• Initial Report FDA Received Date: 02/21/2025
• Supplement Report FDA Received Date: 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2024
• 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