MAUDE Adverse Event Report: ARTHREX, INC. GLENOID DRILL GUIDE HANDLE, LONG; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number	GLENOID DRILL GUIDE HANDLE, LONG
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is now reportable.During returned device evaluation, a reportable malfunction was discovered.Complaint confirmed, the distal end of the threaded tip is chipped.The device laser markings were found to be faded.The device was found to meet material specification and the major diameter also met specifications.The cause is undetermined, however a likely cause is user-applied mechanical forces.
Event or Problem Description
It was reported, that the ar-9215-01-02, guide handle has a crack in the threading.This is now reportable.During returned device evaluation, a reportable malfunction was discovered.

• Brand Name: GLENOID DRILL GUIDE HANDLE, LONG
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11585411
• Report Number: 1220246-2021-02788
• Device Sequence Number: 3085873
• Product Code: MDM
• UDI-Device Identifier: 00888867059023
• UDI-Public: 00888867059023
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 03/29/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: GLENOID DRILL GUIDE HANDLE, LONG
• Device Catalogue Number: AR-9215-1-02
• Device Lot Number: 4461511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2021
• Initial Report FDA Received Date: 03/29/2021
• Patient Sequence Number: 1