MAUDE Adverse Event Report: ARTHREX, INC. 1.8MM DRILL FOR FIBERTAK; DRILL BIT

Model Number	1.8MM DRILL FOR FIBERTAK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a shoulder stabilization surgery the drill became stuck in the drill guide and broke off.All broken pieces were retrieved out of the patient.There was no harm for patient, operator or third party reported.As the hole was already drilled successfully no additional device was needed to finish the surgery successfully.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Complaint is confirmed.Visual evaluation noted that the drill is stuck inside the driver ar-3610f, and the distal end of the flutes and the drill chuck feature were broken.Also, the end of the flutes has strong abrasion marks.Functional testing was not performed due to the devices being stuck and unable to separate them.The most likely cause of this condition is excessive force/friction during use or insertion.

• Brand Name: 1.8MM DRILL FOR 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: 17164852
• Report Number: 1220246-2023-06938
• Device Sequence Number: 12201733
• Product Code: HTW
• UDI-Device Identifier: 00888867101913
• UDI-Public: 00888867101913
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/20/2023

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 FOR FIBERTAK
• Device Catalogue Number: AR-3600D-2
• Device Lot Number: 15054363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2023
• Initial Report FDA Received Date: 06/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2023
• 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