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

Catalog Number	210110
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/20/2018
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
Leg kept falling to the side while locked into place.Case type: tka.
Additional Manufacturer Narrative
Reported issue: it was reported that the leg kept falling to the side.Product history review: review of the device history records indicate (b)(4) devices were manufactured and accepted into final stock on 02/02/2018.No non-conformances were identified during inspection.Complaint history review a review of complaints related to p/n 210110, lot 19360717 shows no additional complaint(s) related to the failure in this investigation.Material analysis material analysis was not completed as no material failure was alleged.Functional inspection: functional inspection shows that the ball is loose in the sled.The metal retainer rings that tighten over the ball are loose inside their housing.Conclusion: the failure mode was confirmed.Corrective action/preventive action: a review of stryker¿s nc/capa database indicated there has been no nc or capa associated with the product and failure mode reported in this event.
Event or Problem Description
Leg kept falling to the side while locked into place.Case type: tka.

• Brand Name: SLED ASSEMBLY
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 7812814
• Report Number: 3005985723-2018-00513
• Device Sequence Number: 16376263
• Product Code: OLO
• UDI-Device Identifier: 00848486031848
• UDI-Public: 00848486031848
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K172219
• 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): 10/11/2018

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: 210110
• Device Lot Number: 19360717
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/20/2018
• Supplement Date Received by Manufacturer: 10/09/2018
• Initial Report FDA Received Date: 08/24/2018
• Supplement Report FDA Received Date: 10/11/2018
• 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: Hospitalization