MAUDE Adverse Event Report: FH INDUSTRIE ARROW; ARROW CHISEL

Model Number 261103

Device Problem Material Erosion (1214)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/05/2022

Event Type  malfunction  

Event Description

There is a wear in tip of the product.

Event Description

There are a wear in tip of the product.

• Brand Name: ARROW
• Type of Device: 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
• MDR Text Key: 291488896
• Report Number: 3003898228-2022-00004
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 03661489611032
• UDI-Public: 03661489611032
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K093599
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 04/14/2022
• Initial Date FDA Received: 05/10/2022
• Supplement Dates Manufacturer Received: 04/14/2022
• Supplement Dates FDA Received: 06/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1