MAUDE Adverse Event Report: FH INDUSTRIE ARROW; ARROW CHISEL

Model Number	261103
Medical Device Problem Code	Material Erosion (1214)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
There is a wear in tip of the product.
Event or Problem Description
There are a wear in tip of the product.

• Brand Name: ARROW
• Common Device Name: ARROW CHISEL
• 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 forêt; heimsbrunn, 68990 ; FR 68990
• MDR Report Key: 14346328
• Report Number: 3003898228-2022-00004
• Device Sequence Number: 5220404
• Product Code: KWT
• UDI-Device Identifier: 03661489611032
• UDI-Public: 03661489611032
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K093599
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2022

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 Model Number: 261103
• Device Lot Number: RC7287-14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/14/2022
• Supplement Date Received by Manufacturer: 04/14/2022
• Initial Report FDA Received Date: 05/10/2022
• Supplement Report FDA Received Date: 06/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• 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