MAUDE Adverse Event Report: ARTHREX, INC. DRILL GUIDE, 1.2 / 1.6MM; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number	DRILL GUIDE, 1.2 / 1.6MM
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2021
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
It was reported that during a procedure, the ar-18700-14 and ar-18700-12 drill bits broke.The sales rep stated that the bars are catching.The case was completed without any adverse event.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-18700-14, 1391932 drill guide was received for investigation.Visual inspection with both the naked eye and under micro-vu magnification identified that both drill guide tunnels were occluded by debris, especially the ø1.6 end.Through the use of added microscope magnification and lighting, it was determined that both ends of the guide were clogged with tissue.The observed condition is most likely the result of improper cleaning/maintenance of the drill guide.

• Brand Name: DRILL GUIDE, 1.2 / 1.6MM
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11912010
• Report Number: 1220246-2021-03181
• Device Sequence Number: 14217927
• Product Code: MDM
• UDI-Device Identifier: 00888867313798
• UDI-Public: 00888867313798
• 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): 06/22/2021

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: DRILL GUIDE, 1.2 / 1.6MM
• Device Catalogue Number: AR-18700-14
• Device Lot Number: 1391932
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/14/2021
• Supplement Date Received by Manufacturer: 05/14/2021
• Initial Report FDA Received Date: 06/01/2021
• Supplement Report FDA Received Date: 06/22/2021
• Patient Sequence Number: 1