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	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	06/03/2024
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 06/03/2024, it was reported by a sales representative via (b)(4) that an ar-9929bc-cp 3.9mm bc achilles pars/ amss cc drill ended up breaking off.This occurred during an achilles repair using the pars and midstubstance kit.They inserted the guidewire to drill with our 2.6 cannulated drill at a 45-degree angle in the drill.The patient's bone was so hard that the drill ended up breaking off into the patient's bone.They were not aware of this until they tried to insert the anchor, and the inserter bent because drill shavings were stopping the anchor from entering.Another kit was opened because they needed a new 3.9 swivelock.The surgeon decided to drill again using the solid 2.6 drill in a different hole.The case was completed as per usual and the repair was finished.Before the skin was closed, the surgeon took x-rays to see if they could get the remainder of the drill out of the patient.The x-ray showed that it was lodged inside the calcaneus.The surgeon decided it would be better to leave the drill piece inside of the patient instead of making a larger incision and removing part of his bone to find this piece.The incisions were closed, and jumpstart dressing was placed on top of the incisions.
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 a most likely cause.The most likely cause for the reported failure can be attributed to improper bone prep; misaligned insertion; prying/leveraging the device during insertion.

• 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: 19645912
• Report Number: 1220246-2024-06529
• Device Sequence Number: 12408836
• Product Code: HWC
• UDI-Device Identifier: 00888867389564
• UDI-Public: 00888867389564
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/13/2025

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: 15237773
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2024
• Supplement Date Received by Manufacturer: 06/06/2024; 06/06/2025
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 12/18/2024; 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown