MAUDE Adverse Event Report: MAKO SURGICAL CORP. 2-PIN CLAMP- ASSEMBLY; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number	112270
Medical Device Problem Codes	Loose or Intermittent Connection (1371); 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 crossthreaded.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
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.Product evaluation and results: visual inspection.Visual inspection confirmed internally deformed threads.  dimensional inspection: dimensional inspection was not completed since visual and functional inspection confirmed internally damaged threads.  functional inspection: functional inspection confirmed adaptor would not tighten due to internally deformed threads.Product history review: review of the product history records as attempted for the indicated device under catalog # 206693, lot no 19050412, but no inspection results were found or non-conformances noted.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 206693, lot number 112270, shows 00 additional complaints related to the failure in this investigation.Conclusions: the reported event was confirmed.

• Brand Name: 2-PIN CLAMP- ASSEMBLY
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8288989
• Report Number: 3005985723-2019-00083
• Device Sequence Number: 1946702
• Product Code: OLO
• UDI-Device Identifier: 00848486015909
• UDI-Public: 00848486015909
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K112507
• 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): 12/10/2019

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: 112270
• Device Lot Number: 19050412 /111430
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2019
• Initial Date Received by Manufacturer: 01/10/2019
• Supplement Date Received by Manufacturer: 11/12/2019
• Initial Report FDA Received Date: 01/30/2019
• Supplement Report FDA Received Date: 12/10/2019
• 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