MAUDE Adverse Event Report: MAKO SURGICAL CORPORATION MAKO HANDPIECE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 06/03/2021

Event Type  malfunction  

Event Description

During surgery, mako handle trigger release piece popped off.Unsure where it went, x-ray was called, surgeon continued working and instructed x-ray tech that he would call her back when ready.Team continued working.Mako rep found piece on floor next to bed.Piece found was approximately 1 inch long and had appearance of headless nail.Mako rep said he would reorder replacement piece for mako handle.

• Brand Name: MAKO HANDPIECE
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORPORATION; 3365 enterprise ave; weston FL 33331
• MDR Report Key: 13235568
• MDR Text Key: 283678986
• Report Number: 13235568
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/05/2022
• Event Location: Hospital
• Date Report to Manufacturer: 01/12/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 20075 DA
• Patient Sex: Male