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

Model Number	270812
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Breakage of the threading of the connection screw with the nailing hoop stuck in the thread of the nail in place.It is impossible to remove this piece, which obstructs the conduit and prevents the nail from being extracted.After numerous attempts with a broken screwdriver, the nail cannot be removed except by aggressively releasing the first centimetre, with an unfavourable risk/benefit ratio.The proximal screws were left in place to prevent the nail from migrating intramedullary removal of the distal screws and closure.The nail could not be removed.
Event or Problem Description
Breakage of the threading of the connection screw with the nailing hoop stuck in the thread of the nail in place.It is impossible to remove this piece, which obstructs the conduit and prevents the nail from being extracted.After numerous attempts with a broken screw driver, the nail cannot be removed except by aggressively releasing the first centimetre, with an unfavourable risk/benefit ratio.The proximal screws were left in place to prevent the nail from migrating intramedullary.Removal of the distal screws and closure.The nail could not be removed.

• Brand Name: TELEGRAPH EVO
• Common Device Name: TELEGRAPH EVO CANNULATED CONNECTING SCREW
• 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: hind chouibani ; 6 rue nobel; quimper, 29000 ; FR 29000
• MDR Report Key: 24590338
• Report Number: 3003898228-2026-00001
• Device Sequence Number: 8860827
• 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: Administrator/Supervisor
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/28/2026

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: 270812
• Device Lot Number: CM40969
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2026
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/03/2026
• Supplement Date Received by Manufacturer: 04/03/2026; 04/03/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 05/26/2026; 05/28/2026
• 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