MAUDE Adverse Event Report: FH INDUSTRIE ARROW; ARROW INSERT HUMERAL STD D36 H10 USA

Model Number	265143
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Std humaral insert defragmented during implantation.Metal base plate separated from polyethylene.

• Brand Name: ARROW
• Common Device Name: ARROW INSERT HUMERAL STD D36 H10 USA
• 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: 12934998
• Report Number: 3006898228-2021-00011
• Device Sequence Number: 14501223
• Product Code: KWS
• UDI-Device Identifier: 03661489651434
• UDI-Public: 03661489651434
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K112193
• 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: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 12/03/2021

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
• Device Model Number: 265143
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2021
• Initial Report FDA Received Date: 12/06/2021
• Was Device Evaluated by Manufacturer? (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