MAUDE Adverse Event Report: ARTHREX, INC. REVERS HUMERAL CUP SCREW GUIDE, 36MM; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number	REVERS HUMERAL CUP SCREW GUIDE, 36MM
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is now reportable.During returned device evaluation, a reportable malfunction was discovered.Complaint confirmed, the device not only cracked but broke in two discrete pieces.The cause of the event is undetermined, however a likely cause is user-applied mechanical forces.
Event or Problem Description
It was reported that the ar-9532-36 cracked during a procedure.No patient harm.This is now reportable.During returned device evaluation, a reportable malfunction was discovered.
Additional Manufacturer Narrative
Complaint confirmed, the device not only cracked but broke in two discrete pieces.The cause of the event is undetermined, however a likely cause is user-applied mechanical forces.

• Brand Name: REVERS HUMERAL CUP SCREW GUIDE, 36MM
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11613238
• Report Number: 1220246-2021-02834
• Device Sequence Number: 17018722
• Product Code: MDM
• UDI-Device Identifier: 00888867241596
• UDI-Public: 00888867241596
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 05/05/2021

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: REVERS HUMERAL CUP SCREW GUIDE, 36MM
• Device Catalogue Number: AR-9532-36
• Device Lot Number: 1027261613
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/10/2021
• Initial Date Received by Manufacturer: 03/16/2021
• Supplement Date Received by Manufacturer: 03/16/2021
• Initial Report FDA Received Date: 04/05/2021
• Supplement Report FDA Received Date: 05/05/2021
• Patient Sequence Number: 1