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

Model Number	1.8MM DRILL BIT, KNOTLESS HIP FIBERTAK
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/26/2022
Type of Reportable Event	Malfunction
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.
Event or Problem Description
On (b)(6) 2022, it was reported by a sales representative via email that an ar-3600d-2h drill broke about 20mm into the patients acetabulum.This was discovered during a hip scope procedure.Additional information received 1/27/2022: this was discovered during a labral repair procedure.After the drill bit broke, surgeon did not remove the broken fragments and it still remains in the patient.
Additional Manufacturer Narrative
The complaint is confirmed based on the customer provided photo, which displays the broken drill tip.However, without return of the device for physical evaluation, the cause remains undetermined.No change in harm was identified.

• Brand Name: 1.8MM DRILL BIT, KNOTLESS HIP FIBERTAK
• Common Device Name: BIT, DRILL
• 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: vik bajnath ; 8009337001
• MDR Report Key: 13526263
• Report Number: 1220246-2022-04446
• Device Sequence Number: 4524242
• Product Code: HTW
• UDI-Device Identifier: 00888867298019
• UDI-Public: 00888867298019
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 06/30/2022

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2022
• Supplement Date Received by Manufacturer: 01/26/2022
• Initial Report FDA Received Date: 02/14/2022
• Supplement Report FDA Received Date: 06/30/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown