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

Catalog Number	270812
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During the surgery, the screw holding the nail to the nail holder broke inside the implant.Despite this, we managed to remove the broken screw thread from the implant.The implant could finally be used because the team managed to extract the broken screw fragment.At the end of the operation, there was no proximal or distal targeting device, which made it difficult to lock the nail.In the end, the surgeon was able to insert 1 proximal screw but no distal screw.Increase in operating time: the operation lasted approximately 3 hours.
Event or Problem Description
During the surgery, the screw holding the nail to the nail holder broke inside the implant.Despite this, we managed to remove the broken screw thread from the implant.The implant could finally be used because the team managed to extract the broken screw fragment.At the end of the operation, there was no proximal or distal targeting device, which made it difficult to lock the nail.In the end, the surgeon was able to insert 1 proximal screw but no distal screw.Increase in operating time: the operation lasted approximately 3 hours.

• Brand Name: TELEGRAPH EVO
• Common Device Name: TELEGRAPH EVO CANNULATED CONNECTING SCREW FOR NAIL
• 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: 19141987
• Report Number: 3003898228-2024-00005
• Device Sequence Number: 7335169
• 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
• Report Date (Section B): 10/11/2024

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: CM26937
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/15/2024
• Initial Report FDA Received Date: 04/19/2024
• Supplement Report FDA Received Date: 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/22/2021
• 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