MAUDE Adverse Event Report: FH INDUSTRIE TELEGRAPH EVO; TELEGRAPH EVO CANNULATED CONNECTING SCREW FOR NAIL

Catalog Number	270812
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Connection screw broken in the nail.The nail had to be taken out because it was too deep and a new one put in.Loss of time.
Event or Problem Description
Connection screw broken in the nail.The nail had to be taken out because it was too deep and a new one put in.Loss of time.

• Brand Name: TELEGRAPH EVO
• Common Device Name: TELEGRAPH EVO CANNULATED CONNECTING SCREW FOR NAIL
• 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: 18543750
• Report Number: 3003898228-2024-00001
• Device Sequence Number: 18069525
• Product Code: HSB
• UDI-Device Identifier: 03661489708121
• UDI-Public: 03661489708121
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K200127
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• 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): 03/22/2024

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 Catalogue Number: 270812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/03/2024
• Supplement Date Received by Manufacturer: 01/03/2024
• Initial Report FDA Received Date: 01/19/2024
• Supplement Report FDA Received Date: 03/22/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown