MAUDE Adverse Event Report: ARTHREX, INC. 1.8MM DRILL BIT, KNOTLESS HIP FIBERTAK

Model Number	1.8MM DRILL BIT, KNOTLESS HIP FIBERTAK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 11/01/2023, it was reported by a sales representative via (b)(4) that an ar-3600d-2h drill broke.This occurred during a hip labral repair where the fragment was retrieved and the case completed with no further issue.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 complaint is confirmed.Functional testing was not performed on the returned ar-3600d-2h due to the damage to the tip of the device.Visual evaluation noted that the tip of the device is broken off and was returned.The most likely cause for the reported failure can be attributed to use error due to excessive user-applied mechanical forces.Refer to investigation photo.

• Brand Name: 1.8MM DRILL BIT, KNOTLESS HIP FIBERTAK
• 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: 18229317
• Report Number: 1220246-2023-08990
• Device Sequence Number: 17695146
• Product Code: HTW
• UDI-Device Identifier: 00888867298019
• UDI-Public: 00888867298019
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 11/21/2024

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: 1.8MM DRILL BIT, KNOTLESS HIP FIBERTAK
• Device Catalogue Number: AR-3600D-2H
• Device Lot Number: 022236
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2023
• Supplement Date Received by Manufacturer: 01/10/2024
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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