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	01/21/2021
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.
Event or Problem Description
It was reported that the tip of the ar-9215-1-02 broke while being removed from the patient during an apex total shoulder procedure.All fragments were fully retrieved, and the device was no longer needed to complete the case.The rep reported that the issue did not affect the outcome nor the actual surgery.
Additional Manufacturer Narrative
Complaint confirmed, the threaded tip was found to be broken.The device was found to meet dimensional and material specifications.The cause of the event is undetermined, however a likely cause of the event is prying/leveraging the device during use.

• 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: 11274733
• Report Number: 1220246-2021-02536
• Device Sequence Number: 3737666
• Product Code: MDM
• UDI-Device Identifier: 00888867059023
• UDI-Public: 00888867059023
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 02/16/2021

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: 04511726
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/21/2021
• Supplement Date Received by Manufacturer: 01/21/2021
• Initial Report FDA Received Date: 02/03/2021
• Supplement Report FDA Received Date: 02/16/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other