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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FH INDUSTRIE CALCANAIL CALCANAIL TREPHINE D12

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FH INDUSTRIE CALCANAIL CALCANAIL TREPHINE D12 Back to Search Results
Model Number 265573
Device Problem Material Fragmentation (1261)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/21/2021
Event Type  malfunction  
Event Description
During a arthrodesis procedure, the calcanail trephine broke at its distal end when passing through the joint to place the nail. This incident resulted in the release of 9 metal fragments into the patient which had to be recovered. The surgeon was able to remove all the fragments from the patient. There were no clinical consequences for the patient.
 
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Brand NameCALCANAIL
Type of DeviceCALCANAIL TREPHINE D12
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
cécilia hernoux
3 rue de la foret
heimsbrunn, 68990
FR   68990
MDR Report Key12779720
MDR Text Key283091564
Report Number3003898228-2021-00008
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K150463
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other Health Care Professional
Remedial Action Replace
Type of Report Initial
Report Date 11/12/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number265573
Device Lot NumberB90113
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/12/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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