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

Model Number 209063

Device Problems Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907)

Event Date 03/02/2022

Event Type  malfunction  

Event Description

While surgeon was using the saw, the drill handle got loose and fell on the ground.A sterile equipment was replaced.No injury to the patient noted.Rn (registered nurse) was scrubbing for this surgery.She states that nothing was out of the ordinary with how the drill connected to the mako.All connections went as usual.She states that the drill just came apart and fell off of the connection to the mako.No parts fell into the patient.

• Brand Name: MICS HANDPIECE
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 13769284
• MDR Text Key: 287194624
• Report Number: 13769284
• 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: Nurse
• Report Date: 03/09/2022

1 Device was Involved in the Event

• Date FDA Received: 03/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 209063
• Device Catalogue Number: 209063
• Device Lot Number: 42010620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/09/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/15/2022
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown