FDA Adverse Event Malfunction Summary report: N

TELEGRAPH

MDR report key: 23534331 · Received November 12, 2025

Report

Report Number
3003898228-2025-00004
Event Type
Malfunction
Date Received
November 12, 2025
Date of Event
September 29, 2025
Report Date
February 20, 2026
Manufacturer
FH INDUSTRIE
Product Code
HSB
UDI-DI
03661489508554
PMA / PMN Number
K023241
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
FR
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL
Health Professional
Yes

Narratives

Description of Event or Problem · 0

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.

Description of Event or Problem · 0

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.

Description of Event or Problem · 0

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.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2034083 TELEGRAPH TELEGRAPH DRILL WITH AO CONNECTION D2,5 L60 HSB FH INDUSTRIE SM53023 03661489508554

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown Other