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

Catalog Number	160245
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/05/2018
Type of Reportable Event	Malfunction
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
During reduction results surgeon broke prong off distal end of femoral array stem.Prong was located in variable angle screw.Tha procedure.
Event or Problem Description
During reduction results surgeon broke prong off distal end of femoral array stem.Prong was located in variable angle screw.Tha procedure.
Additional Manufacturer Narrative
Reported event: it was reported that during reduction results surgeon broke prong off distal end of femoral array stem.Prong was located in variable angle screw.Tha procedure.Product evaluation and results: visual inspection: visual inspection shows broken pin on 160245 array post.Dimensional inspection: dimensional inspection was not completed since visual inspection confirmed broken pin on 160245 array post.Functional inspection: functional inspection was not completed since visual inspection confirmed broken pin on 160245 array post.Product history review: review of the product history records indicate 51 devices were manufactured under lot no w29586.And accepted into final stock on 11/12/ 2012.No non-conformances were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 160245, lot w29586.Shows no additional complaints related to the failure in this investigation.Conclusions: visual inspection confirms broken pin on160245 array post.Functional inspection was not completed since visual inspection confirmed broken pin on 160245 array post.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.

• Brand Name: FEMORAL ARRAY POST ASSEMBLY
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 7658870
• Report Number: 3005985723-2018-00401
• Device Sequence Number: 1108606
• Product Code: OLO
• UDI-Device Identifier: 00848486003142
• UDI-Public: 00848486003142
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 01/02/2019

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: 160245
• Device Lot Number: W29586
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/05/2018
• Supplement Date Received by Manufacturer: 12/26/2018
• Initial Report FDA Received Date: 07/03/2018
• Supplement Report FDA Received Date: 01/02/2019
• 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