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 04/22/2022

Event Type  malfunction  

Event Description

The drill guide and the reamer stuck to each other during surgery.

Event Description

The drill guide and the reamer stuck to each other during surgery.

Event Description

The drill guide and the reamer stuck to each other during surgery.

• 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: 14464019
• MDR Text Key: 300316649
• Report Number: 3003898228-2022-00006
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 03661489694837
• UDI-Public: 03661489694837
• 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
• Report Date: 07/19/2022

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: N00273
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/22/2022
• Initial Date FDA Received: 05/20/2022
• Supplement Dates Manufacturer Received: 04/22/2022; 04/22/2022
• Supplement Dates FDA Received: 06/20/2022; 07/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2022
• 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