MAUDE Adverse Event Report: FH INDUSTRIE TELEGRAPH; TELEGRAPH HUMERAL NAIL D7 L250

Catalog Number	246086
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
When the telegraph nail is inserted (after reaming) and during the to-and-fro movement, the nail is "twisted" at the proximal screwing (slightly narrow medullary canal).Change of device.
Event or Problem Description
When the telegraph nail is inserted (after reaming) and during the to-and-fro movement, the nail is "twisted" at the proximal screwing (slightly narrow medullary canal).Change of device.

• Brand Name: TELEGRAPH
• Common Device Name: TELEGRAPH HUMERAL NAIL D7 L250
• 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: 18695238
• Report Number: 3003898228-2024-00003
• Device Sequence Number: 17910057
• Product Code: HSB
• UDI-Device Identifier: 03661489460869
• UDI-Public: 03661489460869
• 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: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2024

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 Expiration Date: 05/31/2024
• Device Catalogue Number: 246086
• Device Lot Number: N01439
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/19/2024
• Supplement Date Received by Manufacturer: 01/19/2024
• Initial Report FDA Received Date: 02/13/2024
• Supplement Report FDA Received Date: 05/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/27/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown