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

Model Number	267056
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Surgeon guided 12mm reamer over olive guide wire and upon exerting pressure while drilling into the calcaneus we heard a crack.On viewing on x-ray we could see that the base on the 12mm reamer had spanned.Surgeon than removed the drill from reamer attachment and proceeded to pull reamer out with wrench and mallet.
Event or Problem Description
Surgeon guided 12mm reamer over olive guide wire and upon experting pressure while drilling into the calcaneus we heard a crack.On viewing on x-ray we could see that the base on the 12mm reamer had spanned.Surgeon than removed the drill from reamer attachment and proceeded to pull reamer out with wrench and mallet.
Event or Problem Description
Surgeon guided 12mm reamer over olive guide wire and upon experting pressure while drilling into the calcaneus we heard a crack.On viewing on x-ray we could see that the base on the 12mm reamer had spanned.Surgeon than removed the drill from reamer attachment and proceeded to pull reamer out with wrench and mallet.

• Brand Name: CALCANAIL
• Common Device Name: CALCANAIL AO LARGE THREADED TREPHINE D12 L140
• Manufacturer (Section D): FH INDUSTRIE; 6 rue nobel; quimper, 29000 ; FR 29000
• MDR Report Key: 12131413
• Report Number: 3003898228-2021-00003
• Device Sequence Number: 17042221
• Product Code: HSB
• UDI-Device Identifier: 03661489670565
• UDI-Public: 03661489670565
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K150463
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/14/2021

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 Model Number: 267056
• Initial Date Received by Manufacturer: 06/14/2021
• Supplement Date Received by Manufacturer: 06/14/2021; 06/14/2021
• Initial Report FDA Received Date: 07/07/2021
• Supplement Report FDA Received Date: 08/10/2021; 09/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1