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

Catalog Number	270812
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During a surgical procedure, a centromedular nailing of the humerus using a new trial ancillary (telegraph long fh nail) the nail holder broke at the level of the screw thread, remaining in the nail.Difficulty to be expected when removing osteosynthesis material.
Event or Problem Description
During a surgical procedure, a centromedular nailing of the humerus using a new trial ancillary (telegraph long fh nail) the nail holder broke at the level of the screw thread, remaining in the nail.Difficulty to be expected when removing osteosynthesis material.
Event or Problem Description
During a surgical procedure, a centromedular nailing of the humerus using a new trial ancillary (telegraph long fh nail) the nail holder broke at the level of the screw thread, remaining in the nail.Difficulty to be expected when removing osteosynthesis material.

• Brand Name: TELEGRAPH EVO
• Common Device Name: TELEGRAPH EVO CANNULATED CONNECTING SCREW FOR NAIL
• Manufacturer (Section D): FH INDUSTRIE; 6 rue nobel; quiper, 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: 17834667
• Report Number: 3003898228-2023-00005
• Device Sequence Number: 15317683
• 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,Followup
• Report Date (Section B): 01/26/2024

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/05/2023
• Supplement Date Received by Manufacturer: 09/05/2023; 09/05/2023
• Initial Report FDA Received Date: 09/28/2023
• Supplement Report FDA Received Date: 11/17/2023; 01/26/2024
• 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