MAUDE Adverse Event Report: FH INDUSTRIE CALCANAIL; CALCANAIL TREPHINE D12

Model Number	265573
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During a arthrodesis procedure, the calcanail trephine broke at its distal end when passing through the joint to place the nail.This incident resulted in the release of 9 metal fragments into the patient which had to be recovered.The surgeon was able to remove all the fragments from the patient.There were no clinical consequences for the patient.
Event or Problem Description
During a arthrodesis procedure, the calcanail trephine broke at its distal end when passing through the joint to place the nail.This incident resulted in the release of 9 metal fragments into the patient which had to be recovered.The surgeon was able to remove all the fragments from the patient.There were no clinical consequences for the patient.

• Brand Name: CALCANAIL
• Common Device Name: CALCANAIL TREPHINE D12
• 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 foret; heimsbrunn, 68990 ; FR 68990
• MDR Report Key: 12779720
• Report Number: 3003898228-2021-00008
• Device Sequence Number: 20363328
• Product Code: HSB
• UDI-Device Identifier: 03661489655739
• UDI-Public: 03661489655739
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K150463
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2021

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: 265573
• Device Lot Number: B90113
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/12/2021
• Supplement Date Received by Manufacturer: 10/12/2021
• Initial Report FDA Received Date: 11/09/2021
• Supplement Report FDA Received Date: 04/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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