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

Model Number	210080
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As part of normal complaint follow-up, an evaluation of the event has been initiated by mako surgical.A supplemental report will be submitted when additional information becomes available.
Event or Problem Description
Leg positioner boot became detached from the metal spike.Surgical delay: = 15 minutes.Case type / application: tka.
Additional Manufacturer Narrative
Reported event: an event regarding damage (placement cone detached) involving a mako leg holder was reported.The event was confirmed based on inspection of the returned product.Method & results: product evaluation and results: visual inspection confirms the boot assembly silver peg has broken off.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate devices were manufactured and accepted into final stock between with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: the event was confirmed based on inspection of the returned product.Visual inspection confirms the boot assembly silver peg has broken off.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.
Event or Problem Description
Leg positioner boot became detached from the metal spike.Surgical delay: = 15 minutes.Case type / application: tka.

• Brand Name: BOOT ASSEMBLY
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 10992250
• Report Number: 3005985723-2020-00386
• Device Sequence Number: 777689
• Product Code: OLO
• UDI-Device Identifier: 00848486031879
• UDI-Public: 00848486031879
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2021

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: 210080
• Device Catalogue Number: 210080
• Device Lot Number: 201543030601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2021
• Initial Date Received by Manufacturer: 12/03/2020
• Supplement Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 12/11/2020
• Supplement Report FDA Received Date: 04/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other