MAUDE Adverse Event Report: ARTHREX, INC. IMPL SYS,BIO-COMP ACHILLES MID-SUBSTANCE; BIO SOFT TISSUE FIXATN FASTNR

Model Number	IMPL SYS,BIO-COMP ACHILLES MID-SUBSTANCE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 4/3/2025, it was reported by a distributor via email that one of the swivelock anchors from an ar-8929bc-cp achilles mid substance speedbridge implant system broke during insertion.This was discovered during a procedure on (b)(6) 2025.Additional information requested on 4/30/2025.
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 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 for the reported failure can be attributed to user error, including improper bone preparation and misalignment of the insertion.The complaint allegation was confirmed based on the customer's attached picture, which shows an anchor displayed broken into two pieces.

• Brand Name: IMPL SYS,BIO-COMP ACHILLES MID-SUBSTANCE
• 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: 21942405
• Report Number: 1220246-2025-01824
• Device Sequence Number: 8382195
• Product Code: MAI
• UDI-Device Identifier: 00888867131651
• UDI-Public: (01)00888867131651(11)240712(17)280630(10)15287133
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,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: IMPL SYS,BIO-COMP ACHILLES MID-SUBSTANCE
• Device Catalogue Number: AR-8929BC-CP
• Device Lot Number: 15287133
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/03/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2025
• Supplement Date Received by Manufacturer: 09/25/2025
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 09/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown