MAUDE Adverse Event Report: MAKO SURGICAL CORP. ARRAY CLAMP ASSEMBLY; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number	112100
Medical Device Problem Codes	Mechanical Problem (1384); Output Problem (3005)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/10/2019
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
During case, where the 2 pin clamp attaches to array adaptor it is cross threaded.It would not tighten the array enough to hold it in place.Case type: pka.Provide more detail: when noticed has already finished cuts however weren't able assess leg with trials because array would not hold in place.Surgical delay: 10 minutes.
Event or Problem Description
During case, where the 2 pin clamp attaches to array adaptor it is cross threaded.It would not tighten the array enough to hold it in place.Case type: pka.Provide more detail: when noticed has already finished cuts however weren¿t able assess leg with trials because array would not hold in place.Surgical delay: 10 minutes.
Additional Manufacturer Narrative
Reported event: it was reported that "during case, where the 2 pin clamp attaches to array adaptor it is cross threaded.It would not tighten the array enough to hold it in place.Case type: pka.Provide more detail: when noticed has already finished cuts however weren¿t able assess leg with trials because array would not hold in place.Surgical delay: 10 minutes." the event was confirmed.Method & results: device evaluation and results: visual inspection: the adaptor showed signs of damage.See attached images.Functional inspection: the device is non-functional.Product history review: review of the device history records indicates 40 device(s) were manufactured and accepted into final stock on 23oct2012 with no reported discrepancies.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 112100, lot 19020412 shows 00 additional complaint(s) related to the failure in this investigation.Conclusion: the investigation concluded that alleged failure mode was caused by damage.Product surveillance will continue to monitor for trends.Corrective action/preventive action: no action is required at this time as there is no indication or evidence available at this time to suggest that there was a product non- conformity or unanticipated hazard.Should additional information become available the investigation will be reopened and re-evaluated.

• Brand Name: ARRAY CLAMP ASSEMBLY
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8288979
• Report Number: 3005985723-2019-00084
• Device Sequence Number: 2463322
• Product Code: OLO
• UDI-Device Identifier: 00848486002930
• UDI-Public: 00848486002930
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 10/30/2019

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: 112100
• Device Lot Number: 19020412/112100
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/10/2019
• Supplement Date Received by Manufacturer: 10/29/2019
• Initial Report FDA Received Date: 01/30/2019
• Supplement Report FDA Received Date: 10/30/2019
• 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