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

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.

• Brand Name: CALCANAIL
• Type of Device: CALCANAIL 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 Key: 10337799
• MDR Text Key: 202367392
• Report Number: 3003898228-2020-00006
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K150463
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 267056
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2020
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1