MAUDE Adverse Event Report: MAKO SURGICAL CORP.; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 213524

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/14/2021

Event Type  malfunction  

Event Description

The schanz screw broke at the surface of the bone when drilling in.Broken piece confined to the tibia and did not extend out the cortex.Retained pin not removed to avoid more trauma.

• Brand Name: NA
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 13590942
• MDR Text Key: 286059425
• Report Number: 13590942
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 213524
• Device Catalogue Number: 213524
• Device Lot Number: 48050421
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/10/2022
• Event Location: Hospital
• Date Report to Manufacturer: 02/24/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28835 DA
• Patient Sex: Male