MAUDE Adverse Event Report: GLOBAL MANUFACTURING TECHNOLOGY PTY LTD PARAGON PLANAR CALCAR MILL; BONE MILL

Model Number GM14003-3134-40

Device Problem Degraded (1153)

Patient Problem Bone Fracture(s) (1870)

Event Date 01/31/2023

Event Type  Injury  

Manufacturer Narrative

Surgeon stated that he has had 2 patients with fractured femurs due to paragon planar calcar mills being blunt and not taking bone.The bluntness of the device causes the surgeon to push too hard, resulting in the device then catching and rotating on the bone, thus leading to fracture.Please note: the submission of this report does not constitute an admission that the device, reporting entity, entity's representative or distributor caused or contributed to the event.This report is filed with the fda due to an event experienced with a device that is similar to those placed on the market in the usa, however, this event occurred outside of the usa.

Event Description

Surgeon stated that he has had 2 patients with fractured femurs due to paragon planar calcar mills being blunt and not taking bone.The bluntness of the device causes the surgeon to push too hard, resulting in the device then catching and rotating on the bone, thus leading to fracture.

• Brand Name: PARAGON PLANAR CALCAR MILL
• Type of Device: BONE MILL
• Manufacturer (Section D): GLOBAL MANUFACTURING TECHNOLOGY PTY LTD
• Manufacturer (Section G): GLOBAL MANUFACTURING TECHNOLOGY PTY LTD
• Manufacturer Contact: ayesha ghazan ; pymble 2073 ; AS 2073
• MDR Report Key: 16386005
• MDR Text Key: 309683856
• Report Number: 3004537778-2023-00007
• Device Sequence Number: 1
• Product Code: LYS
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GM14003-3134-40
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/31/2023
• Date Manufacturer Received: 01/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1