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 Codes	Positioning Failure (1158); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/26/2025
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 08/27/2025, a sales representative reported via email that the end of the driver from an ar-9929bc-cp 3.9 mm biocomposite achilles pars/amss cc twisted and broke off inside the patient, with the screw still attached.The case was completed, and the broken piece was retrieved from the patient.This was discovered during a pars procedure on (b)(6) 2025.Additional information received on 9/3/2025: the issue occurred toward the end of the case during the first attempt at inserting a swivelock anchor.The implant failed to deploy.All detached fragments were accounted for and retrieved from the patient.To complete the procedure, a second kit was opened, and the ar-9929bc-cp swivelock was used.The surgery was delayed by approximately 5¿10 minutes, but no additional anesthesia was administered.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 the complaint allegation is confirmed based on the photographic evidence of a broken (b)(4) swivelock anchor, batch 15448295.Based on the information provided ¿ which may include the returned device (if available), photographs, videos, event description, and any additional field input ¿ arthrex has determined the most likely cause.The most likely cause is attributed to misuse due to mechanical overstress of the driver during anchor insertion, such as misalignment, improper trajectory, or the application of excessive torque while attempting to deploy the swivelock anchor.

• 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: 23084445
• Report Number: 1220246-2025-03916
• Device Sequence Number: 13191656
• Product Code: HWC
• UDI-Device Identifier: 00888867389564
• UDI-Public: (01)00888867389564(11)250609(17)290228(10)15448295
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K201749
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2026

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: 15448295
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2025
• Supplement Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/09/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown