MAUDE Adverse Event Report: MAKO SURGICAL CORP. BONE PIN-4MM X 170MM-STERILE 2 PACK; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number	144170
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.
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.It was reported that 4x140 and 4x170 pins cracking the femoral cortex when being drilled in for array placement.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.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.No action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.

• Brand Name: BONE PIN-4MM X 170MM-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: 7586299
• Report Number: 3005985723-2018-00357
• Device Sequence Number: 19403664
• Product Code: OLO
• UDI-Device Identifier: 00848486018184
• UDI-Public: 00848486018184
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K142530
• 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: 144170
• 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