MAUDE Adverse Event Report: FH INDUSTRIE ARROW; ARROW TAPERED DRILL GUIDE MB S44

Model Number 269483

Device Problem Material Frayed (1262)

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

Event Date 12/22/2021

Event Type  malfunction  

Event Description

There are some scratch and burr inside the hole; so this one is not able to pass through reamer.

Event Description

There are some scratch and burr inside the hole; so this one is not able to pass through reamer.

Event Description

There are some scratch and burr inside the hole; so this one is not able to pass through reamer.

Event Description

There are some scratch and burr inside the hole; so this one is not able to pass through reamer.

• Brand Name: ARROW
• Type of Device: ARROW TAPERED DRILL GUIDE MB S44
• 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: 14464109
• MDR Text Key: 300312546
• Report Number: 3003898228-2022-00007
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 03661489694806
• UDI-Public: 03661489694806
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K171789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/04/2022

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: 269483
• Device Lot Number: CM24299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2022
• Initial Date FDA Received: 05/20/2022
• Supplement Dates Manufacturer Received: 04/19/2022; 04/19/2022; 04/19/2022
• Supplement Dates FDA Received: 06/14/2022; 07/12/2022; 08/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1