MAUDE Adverse Event Report: FH INDUSTRIE ARROW; ARROW CHISEL

Model Number 21103

Device Problem Break (1069)

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

Event Date 08/11/2022

Event Type  malfunction  

Event Description

The instrument was received broken.

Event Description

The instrument was received broken.

• 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: el yazid aribi ; 6 rue nobel; quimper, 29000 ; FR 29000
• MDR Report Key: 15441849
• MDR Text Key: 305433187
• Report Number: 3003898228-2022-00010
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 03661489611032
• UDI-Public: 03661489611032
• Combination Product (y/n): N
• Reporter Country Code: SI
• PMA/PMN Number: K093599
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 21103
• Device Lot Number: RC83775
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/23/2022
• Initial Date FDA Received: 09/16/2022
• Supplement Dates Manufacturer Received: 08/23/2022
• Supplement Dates FDA Received: 11/28/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1