MAUDE Adverse Event Report: ARTHREX, INC. DYNANITE® STAPLE DRILL BIT, CAL, 2.0; BIT, DRILL

Model Number	DYNANITE® STAPLE DRILL BIT, CAL, 2.0
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on (b)(6) 2022 by a facility representative via sems that an ar-8717g-02 drill guide has the drill bits stuck in it.This was discovered during a case with no patient harm.Additional information provided 5/3/202: qty.2 of the ar-8717d-02 drill bit is stuck to the ar-8717g-02.It was also noticed that one drill bit has a broke tip.
Additional Manufacturer Narrative
Complaint confirmed.Visual inspection identified that the two drill bits are stuck within drill guide ar-8717g-02 both on the 13 mm end.One drill bit is also missing the tip.The outer diameter of each drill bit was measured and both were found to be 0.121 inches which is within the requirements.

• Brand Name: DYNANITE® STAPLE DRILL BIT, CAL, 2.0
• 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: 14468642
• Report Number: 1220246-2022-04932
• Device Sequence Number: 14672081
• Product Code: HTW
• UDI-Device Identifier: 00888867326200
• UDI-Public: 00888867326200
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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
• Report Date (Section B): 05/23/2022

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: DYNANITE® STAPLE DRILL BIT, CAL, 2.0
• Device Catalogue Number: AR-8717D-02
• Device Lot Number: 032006
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2022
• Initial Report FDA Received Date: 05/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown