MAUDE Adverse Event Report: MAKO SURGICAL CORP. BONE PIN, 4MM X 140MM, STERILE 2 PACK; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number	144140
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/04/2018
Type of Reportable Event	Serious Injury
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
As reported: conversation with dr.(b)(6) about having issues with the 4x140 and 4x170 pins cracking the femoral cortex when being drilled in for array placement.
Additional Manufacturer Narrative
Follow-up #1 and final report submitted to update sections based on the results of investigation.Reported event: it was reported that 4x140 and 4x170 pins cracking the femoral cortex when being drilled in for array placement.Product evaluation and results: the product was unavailable for inspection as the product was not returned.Product history review: not performed as lot no was not provided.Complaint history review: not performed as lot no was not provided.Conclusions: the failure mode could not be confirmed because the part was not available for evaluation.If device and/or additional information become available, this investigation will be reopened.Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.
Event or Problem Description
As reported: conversation with dr.(b)(6) about having issues with the 4x140 and 4x170 pins cracking the femoral cortex when being drilled in for array placement.

• Brand Name: BONE PIN, 4MM X 140MM, STERILE 2 PACK
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 7586291
• Report Number: 3005985723-2018-00354
• Device Sequence Number: 10814186
• Product Code: OLO
• UDI-Device Identifier: 00848486018177
• UDI-Public: 00848486018177
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 08/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 144140
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/04/2018
• Supplement Date Received by Manufacturer: 07/30/2018
• Initial Report FDA Received Date: 06/11/2018
• Supplement Report FDA Received Date: 08/02/2018
• 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