MAUDE Adverse Event Report: FH INDUSTRIE ARROW; ARROW CHISEL

Model Number	21103
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The instrument was received broken.
Event or Problem Description
The instrument was received broken.

• 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: el yazid aribi ; 6 rue nobel; quimper, 29000 ; FR 29000
• MDR Report Key: 15441849
• Report Number: 3003898228-2022-00010
• Device Sequence Number: 14871019
• Product Code: KWT
• UDI-Device Identifier: 03661489611032
• UDI-Public: 03661489611032
• Combination Product (Y/N): N
• Initial Reporter Country: SI
• PMA/510(K) Number: K093599
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2022

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: 21103
• Device Lot Number: RC83775
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/23/2022
• Supplement Date Received by Manufacturer: 08/23/2022
• Initial Report FDA Received Date: 09/16/2022
• Supplement Report FDA Received Date: 11/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown