MAUDE Adverse Event Report: FH INDUSTRIE ARROW; ARROW MB GLENOID BASE PLATE S44 LONG PEG PC

Catalog Number	267703
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
Broken screw revision surgery will be scheduled for november at the patient[?]s request.Dr.(b)(6) would like to change the orientation of the base plate to be more downward.He believes that if the base plate is left in place, the same complication will repeat.
Event or Problem Description
Broken screw.Revision surgery will be scheduled for november at the patient's request.Dr.(b)(6)would like to change the orientation of the base plate to be more downward.He believes that if the base plate is left in place, the same complication will repeat.

• Brand Name: ARROW
• Common Device Name: ARROW MB GLENOID BASE PLATE S44 LONG PEG PC
• 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: 17890222
• Report Number: 3003898228-2023-00013
• Device Sequence Number: 17886563
• Product Code: MBF
• UDI-Device Identifier: 03661489677038
• UDI-Public: 03661489677038
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K162068
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2024

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 Catalogue Number: 267703
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/08/2023
• Supplement Date Received by Manufacturer: 09/08/2023
• Initial Report FDA Received Date: 10/06/2023
• Supplement Report FDA Received Date: 01/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 66 YR
• Patient Sex: Male