MAUDE Adverse Event Report: ARTHREX, INC. 1.70MM DRILL FOR FIBERTAK; BIT, DRILL

Model Number	1.70MM DRILL FOR FIBERTAK
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/28/2019
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that a 1.70mm drill for fibertak, ar-3600d-3, was being used during an arthroscopic bankart repair.The surgeon made three bone holes and deployed fiber tak anchors in each hole with no issue.When the surgeon was drilling the fourth bone hole, the drill tip broke and the broken piece became stuck in the glenoid.The surgeon tried to retrieve the broken piece but could not.The surgical site was closed and the surgery was completed.Additional information provided 9/24/2019: the rep confirmed that tip of the drill bit was secured within the bone.No special measure was taken, but it bites hard into the bones and the surgeon determined that it would not move.
Additional Manufacturer Narrative
Complaint confirmed.Visual evaluation revealed that the returned ar-3600d-3 drill had broken in three pieces.The returned ar-3600d-3 was reviewed for critical dimension at the device diameter.The device met all as received specifications.The observed condition of the returned device is most likely caused by prying/leveraging during use or impacting the device with another object.

• Brand Name: 1.70MM DRILL FOR FIBERTAK
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9118754
• Report Number: 1220246-2019-01328
• Device Sequence Number: 2615002
• Product Code: HTW
• UDI-Device Identifier: 00888867101920
• UDI-Public: 00888867101920
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 1.70MM DRILL FOR FIBERTAK
• Device Catalogue Number: AR-3600D-3
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/03/2019
• Supplement Date Received by Manufacturer: 09/03/2019
• Initial Report FDA Received Date: 09/25/2019
• Supplement Report FDA Received Date: 05/21/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other