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	Foreign Body In Patient (2687)
Date of Event	03/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 04/03/2025, it was reported by a sales representative via (b)(6) that an ar-9929bc-cp 3.9mm bc achilles pars/ amss cc had the 2.6 cannulated drill break off in the patient.The case was completed, but the broken piece was not retrieved from the patient and was left in the patient.This was discovered during an achilles repair procedure on (b)(6) 2025.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, g3.
Event or Problem Description
Additional information was received on 04/22/2025: the fluted portion of the 2.6-cannulated drill bit crumbled in the patient during insertion.No revision surgery is needed, and medical intervention was performed to remove the drill bit fragments.The patient did not experience a reduction in quality of life due to this.The case was completed with the solid 2.6 drill bit.There was no case delay or added anesthesia reported, and no negative effects on or after the surgery were reported.
Event or Problem Description
Additional information was received on 05/22/2025: minimal achilles debridement was performed, and a rongeur was used for extraction.No additional incisions were necessary.The case was completed using solid drill bit drilling, with no changes to the surgical technique.
Additional Manufacturer Narrative
Additional information: b5, h3, h6.
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 not confirmed as the device was not received for evaluation, and no evidence of the failure was provided.

• 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: 21874874
• Report Number: 1220246-2025-01603
• Device Sequence Number: 12737559
• Product Code: HWC
• UDI-Device Identifier: 00888867389564
• UDI-Public: (01)00888867389564(11)250102(17)281031(10)15367395
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,Followup
• Report Date (Section B): 09/25/2025

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: 3.9MM BC ACHILLES PARS/ AMSS CC
• Device Catalogue Number: AR-9929BC-CP
• Device Lot Number: 15367395
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2025
• Supplement Date Received by Manufacturer: 04/22/2025; Not provided; 09/25/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 05/20/2025; 06/16/2025; 09/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/02/2025
• 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