MAUDE Adverse Event Report: FH INDUSTRIE ARROW; ARROW STD HUMERAL INSERT D39 H05

Model Number	265145
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The surgeon reviewed a patient whose initial operation took place on (b)(6).The humeral component was dissociated from the glenoid base plate.
Event or Problem Description
The surgeon reviewed a patient whose initial operation took place on july 11.The humeral component was dissociated from the glenoid base plate.
Event or Problem Description
The surgeon reviewed a patient whose initial operation took place on july 11.The humeral component was dissociated from the glenoid base plate.
Event or Problem Description
The surgeon reviewed a patient whose initial operation took place on (b)(6).The humeral component was dissociated from the glenoid base plate.
Event or Problem Description
The surgeon reviewed a patient whose initial operation took place on july 11.The humeral component was dissociated from the glenoid base plate.

• Brand Name: ARROW
• Common Device Name: ARROW STD HUMERAL INSERT D39 H05
• Manufacturer (Section D): FH INDUSTRIE; 6 rue nobel; quimper, 29000 ; FR 29000
• Manufacturer (Section G): FH INDUSTRIE; 6 rue nobel; quimper, 29000 ; FR 29000
• Manufacturer Contact: el yazid aribi ; 6 rue nobel; quimper, 29000 ; FR 29000
• MDR Report Key: 14464335
• Report Number: 3003898228-2022-00005
• Device Sequence Number: 17302601
• Product Code: KWS
• UDI-Device Identifier: 03661489651458
• UDI-Public: 03661489651458
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K112193
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 09/26/2022

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 Expiration Date: 01/31/2026
• Device Model Number: 265145
• Device Lot Number: E04728
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/20/2022
• Supplement Date Received by Manufacturer: 04/20/2022; 04/20/2022; 04/20/2022; 04/20/2022
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 06/14/2022; 07/19/2022; 08/08/2022; 09/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown