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

Model Number 267056

Device Problems Break (1069); Use of Device Problem (1670); Material Integrity Problem (2978)

Patient Problem No Information (3190)

Event Date 06/25/2019

Event Type  malfunction  

Event Description

While trying to reduce a fracture, the trephine hit a non-fh clamp and/or pin and the trephine shattered.

Manufacturer Narrative

Opening of a change control for modification of the material of the trephines, in order to reinforce the trephine and avoid breakage in the event that too much force is imposed on the instrument (strong bone).

Event Description

While trying to reduce a fracture, the trephine hit a non-fh clamp and/or pin and the trephine shattered.

• 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
• MDR Report Key: 8825264
• MDR Text Key: 153233659
• Report Number: 3003898228-2019-00004
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• PMA/PMN Number: D114496
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 267056
• Device Lot Number: 1706/360/4
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1