MAUDE Adverse Event Report: FH INDUSTRIE CALCANAIL; CALCANAIL CANULATED SCREW D5 L36

Model Number	265555
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Thread seal when tightening the canulated screw into the calcaneal wail hole.Complaint on the reference : (b)(4).- fda equivalence : (b)(4).
Event or Problem Description
Thread seal when tightewing the canulated screw into the calcanail wail hole.Complaint on the reference : (b)(4) - fda equivalence : (b)(4).

• Brand Name: CALCANAIL
• Common Device Name: CALCANAIL CANULATED SCREW D5 L36
• 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: 16038742
• Report Number: 3003898228-2022-00012
• Device Sequence Number: 14683628
• Product Code: FRG
• UDI-Device Identifier: 03661489683237
• UDI-Public: 03661489683237
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K150463
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2023

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: 265555
• Device Lot Number: N01880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/05/2022
• Supplement Date Received by Manufacturer: 12/05/2022
• Initial Report FDA Received Date: 12/22/2022
• Supplement Report FDA Received Date: 02/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/13/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown