MAUDE Adverse Event Report: ARTHREX, INC. 2.8MM CANNULATED DRILL GUIDE, SMALL; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number	2.8MM CANNULATED DRILL GUIDE, SMALL
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2021
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
At this time, no description of the error was received with this device.The information has been requested.Update 07-dec-2021: according to surgical technical assistant: the defect in the cannulated burr small is due to months of use.After all, the wires from arthrex just barely fit through the opening, causing them to break through repeated use.Unfortunately, this leads to increased metal abrasion in the shoulder.The patient was not harmed.Update 07-dec-2021: it is not about a drill guide but about the template ar-9215-2cg glenoid drill guide, nautilus, small.This item has very tight holes for the drill and due to drilling through over the last few years there is now metal abrasion.The metal abrasion has been removed from patient.

• Brand Name: 2.8MM CANNULATED DRILL GUIDE, SMALL
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• 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: 13087702
• Report Number: 1220246-2021-04173
• Device Sequence Number: 17502158
• Product Code: MDM
• UDI-Device Identifier: 00888867192591
• UDI-Public: 00888867192591
• 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): 12/27/2021

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: 2.8MM CANNULATED DRILL GUIDE, SMALL
• Device Catalogue Number: AR-9215-2CG
• Device Lot Number: 121451
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2021
• Initial Report FDA Received Date: 12/27/2021
• Date Device Manufactured: 01/26/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown