MAUDE Adverse Event Report: MAKO SURGICAL CORP. SHELL IMPACTION PLATFORM; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number	206270
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As part of the 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
After impaction the strike plate broke into a few pieces.This resulted in not being able to disassemble remaining piece of the strike plate, the in-line offset impactor(209830-lot unknown), and the end effector(206967 - lot: 19021214).The inline offset might be bent which might be causing the inability to pass through the strike plate.But the end effector should not be damaged in any capacity.However all three pieces are no longer effective.Case type: tha.
Additional Manufacturer Narrative
Follow-up #1 and final report submitted.It was reported that after impaction, the strike plate broke into a few pieces.This resulted in not being able to disassemble the remaining piece of the strike plate from the in-line offset impactor and the end effector.Product evaluation and results: visual inspection: the 206270 shell impaction platform shows wear and tear (indentations on the top of the device and light scratches on the body of the device).The 206270 shell impaction platform is broken in two with the button separate.A picture of the broken device is attached.Functional inspection: the 206270 shell impaction platform was broken in two and the button was loose.The platform could not be used.The failure mode ¿strike plate broke into a few pieces¿ was confirmed.Dimensional inspection: not performed as the item has been used and the dimensions and tolerances on the print are no longer accurately represented by the part.Material analysis: not performed as no material failure is alleged.Product history review: review of the device history records indicate 29 devices were manufactured under lot: 45011115 and 29 devices were rejected for missing documentation on 11/13/2015.The missing documentation was supplied as part of qt-15-11-0040 and all 29 devices were accepted into final stock on 12/15/2015.Complaint history review: review of complaints for p/n: 206270, l/n: 45011115 within the trackwise database show 04 other complaints related to the failure in this investigation.Conclusions: the 206270 shell impaction platform shows wear and tear.The platform was broken in two and the button was loose.The platform could not be used.The failure mode ¿strike plate broke into a few pieces¿ was confirmed.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.
Event or Problem Description
After impaction the strike plate broke into a few pieces.This resulted in not being able to disassemble remaining piece of the strike plate, the in-line offset impactor (209830-lot unknown), and the end effector (206967, lot: 19021214).The inline offset might be bent which might be causing the inability to pass through the strike plate.But the end effector should not be damaged in any capacity.However all three pieces are no longer effective.Case type: tha.

• Brand Name: SHELL IMPACTION PLATFORM
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9081447
• Report Number: 3005985723-2019-00683
• Device Sequence Number: 2657368
• Product Code: OLO
• UDI-Device Identifier: 00848486022082
• UDI-Public: 00848486022082
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K121064
• 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): 12/09/2019

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 Catalogue Number: 206270
• Device Lot Number: 45011115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2019
• Initial Date Received by Manufacturer: 09/13/2019
• Supplement Date Received by Manufacturer: 11/11/2019
• Initial Report FDA Received Date: 09/18/2019
• Supplement Report FDA Received Date: 12/09/2019
• 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: Hospitalization
• Patient Age: 68 YR
• Patient Weight: 94