MAUDE Adverse Event Report: MAKO SURGICAL CORP. BENT HOHMANN RETRACTOR; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number	210191
Medical Device Problem Codes	Material Deformation (2976); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/12/2019
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
Badly gauged retractor found in cpd.Case type: no associated procedure as per the mps: i do not know when exactly the retractor got gauged because it was found on the clean side of cpd after the case.
Additional Manufacturer Narrative
Reported event: -customer reported a badly gauged retractor found in cpd.Device evaluation and results: -device evaluation was not performed and the bent hohmann retractor event was not confirmed.Device history review: -a review of the device history records indicate 199 devices were manufactured and accepted into final stock on 01/23/18 with no discrepancies.Complaint history review: -based on the device identification, the catsweb and trackwise complaint databases were reviewed from 2011 to present for similar reported events regarding the bent hohmann retractor.There have been 3 other events for the referenced lot number.Prs # (b)(4) - were found to be from the same lot as the part in this complaint.The parts from these prs displayed the same failure.Conclusions: -no product inspection could be completed due to the part missing.Per d03391, preventive maintenance identifies device deterioration which may compromise function.Under pm conditions no patient was involved and no actual or potential patient harm existed for the alleged event.No additional investigation or specific actions are required.Corrective action/preventive action: -as the event did not involve a manufacturing related product problem indicating a non-conformity, adverse trend, or unanticipated hazard, no corrective action is required at this time.
Event or Problem Description
Badly gauged retractor found in cpd.Case type: no associated procedure.As per the mps: i do not know when exactly the retractor got gauged because it was found on the clean side of cpd after the case.

• Brand Name: BENT HOHMANN RETRACTOR
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8485735
• Report Number: 3005985723-2019-00284
• Device Sequence Number: 14082313
• Product Code: OLO
• UDI-Device Identifier: 00848486031909
• UDI-Public: 00848486031909
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 06/17/2019

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: 210191
• Device Lot Number: 37833
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/12/2019
• Supplement Date Received by Manufacturer: 05/31/2019
• Initial Report FDA Received Date: 04/04/2019
• Supplement Report FDA Received Date: 06/17/2019
• 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