MAUDE Adverse Event Report: ARTHREX, INC. FASTTHREAD INTERFERENCE SCREW TAP, 9MM; DRILL BIT

Model Number	FASTTHREAD INTERFERENCE SCREW TAP, 9MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023, it was reported by a sales representative via sems that an ar-4020ht-09 fastthread¿ screw tap broke.This occurred during a case, the handle broke loose from the tap into two pieces.There was no additional information provided, additional information has been requested.
Additional Manufacturer Narrative
The contribution of the device to the reported event has not yet been determined as the device has not been returned for evaluation at this time.A follow-up report will be submitted, including a most likely cause if a root cause can not be determined.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint is not confirmed.One unpackaged ar-4020ht-09 serial/batch number (b)(6) was received for investigation.Functional testing found that the driver shaft is attached to the blue silicone handle.Upon visual evaluation, it was noted that no broken or detached parts were from the handle or the shaft.However, it was found damaged/nicks on the threads and shaft.No problem found.
Event or Problem Description
Additional information was provided on 06/26/2023, where it was stated, this event occurred during an acl repair on (b)(6) 2023.It was realized two days after the case that the metal portion of the tap did not disengage from the blue handle as reported and no fragments were produced.The metal portion of the tap was just spinning and not gripping onto any of the cortex, another tap was used to complete the case.This was a younger patient with good bone quality.
Additional Manufacturer Narrative
Additional information: b5, g3.

• Brand Name: FASTTHREAD INTERFERENCE SCREW TAP, 9MM
• Common Device Name: DRILL BIT
• 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: emily shafer ; 8009337001
• MDR Report Key: 17327736
• Report Number: 1220246-2023-07169
• Device Sequence Number: 12426700
• Product Code: HTW
• UDI-Device Identifier: 00888867292000
• UDI-Public: 00888867292000
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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
• 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: FASTTHREAD INTERFERENCE SCREW TAP, 9MM
• Device Catalogue Number: AR-4020HT-09
• Device Lot Number: 022010
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2023
• Supplement Date Received by Manufacturer: 07/20/2023; 06/26/2023
• Initial Report FDA Received Date: 07/14/2023
• Supplement Report FDA Received Date: 10/31/2024; 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2020
• Is the Device Labeled for Single Use? (Y/N): No
• 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