MAUDE Adverse Event Report: FH INDUSTRIE TELEGRAPH; TELEGRAPH DRILL WITH AO CONNECTION D2,5 L60

Catalog Number	250855
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Performing intramedullary nailing of a long open fracture of the upper third of the humerus.Use of a short nail locked with two proximal screws and a distale screw.During surgery the drill was used and then sent to the sterilisation department.The sterilisation department noticed that the distal end of the drill was missing.The operating theatre performed a contol x-ray, during which the tip was not found.It is impossible to determine with certainty that the tip has not remained in the patient's body.
Event or Problem Description
Performing intramedullary nailing of a long open fracture of the upper third of the humerus.Use of a short nail locked with two proximal screws and a distal screw.During surgery the drill was used and then sent to the sterilisation department.The sterilisation department noticed that the distal end of the drill was missing.The operating theatre performed a control x-ray, during which the tip was not found.It is impossible to determine with certainty that the tip has not remained in the patient's body.
Event or Problem Description
Performing intramedullary nailing of a long open fracture of the upper third of the humerus.Use of a short nail locked with two proximal screws and a distale screw.During surgery the drill was used and then sent to the sterilisation department.The sterilisation department noticed that the distal end of the drill was missing.The operating theatre performed a contol x-ray, during which the tip was not found.It is impossible to determine with certainty that the tip has not remained in the patient's body.

• Brand Name: TELEGRAPH
• Common Device Name: TELEGRAPH DRILL WITH AO CONNECTION D2,5 L60
• 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: 23534331
• Report Number: 3003898228-2025-00004
• Device Sequence Number: 13046665
• Product Code: HSB
• UDI-Device Identifier: 03661489508554
• UDI-Public: 03661489508554
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K023241
• 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: Patient Monitoring
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/20/2026

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 Catalogue Number: 250855
• Device Lot Number: SM53023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/24/2025
• Supplement Date Received by Manufacturer: 10/24/2025; 10/24/2025
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 01/20/2026; 02/20/2026
• 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