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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FH INDUSTRIE CALCANAIL CALCANAIL AO LARGE THREADED TREPHINE D12 L140

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FH INDUSTRIE CALCANAIL CALCANAIL AO LARGE THREADED TREPHINE D12 L140 Back to Search Results
Model Number 267056
Device Problems Break (1069); Material Integrity Problem (2978)
Patient Problem No Information (3190)
Event Date 07/10/2020
Event Type  malfunction  
Event Description
The threaded trephine d12 has shatted in use.
 
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Brand NameCALCANAIL
Type of DeviceCALCANAIL AO LARGE THREADED TREPHINE D12 L140
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
hernoux cécilia
3 rue de la forêt
heimsbrunn, 68990
FR   68990
MDR Report Key10337799
MDR Text Key202367392
Report Number3003898228-2020-00006
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeAS
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 08/15/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number267056
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/15/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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