MAUDE Adverse Event Report: FH INDUSTRIE ARROW; ARROW GLENOSPHERE POSITIONER/IMPACTOR

Model Number	269903
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/30/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During the installation of the definitive baseplate, when loosening the glenosphere positioner/impactor from the implant, the connecting bar of the wheel broke off.The instrument is in 3 parts.

• Brand Name: ARROW
• Common Device Name: ARROW GLENOSPHERE POSITIONER/IMPACTOR
• 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: cécilia hernoux ; 3 rue de la foret; heimsbrunn, 68990 ; FR 68990
• MDR Report Key: 13578800
• Report Number: 3003898228-2021-00012
• Device Sequence Number: 4410369
• Product Code: PHX
• UDI-Device Identifier: 03661489699030
• UDI-Public: 03661489699030
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K171789
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 12/31/2021

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: 269903
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2021
• Initial Report FDA Received Date: 02/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown