MAUDE Adverse Event Report: MAKO SURGICAL CORP. HIP END EFFECTOR, VARIABLE ANGLE; STEREOTAXIC DEVICE, ROBOTICS

Model Number 206967

Device Problems Break (1069); Fracture (1260); Detachment of Device or Device Component (2907); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/13/2019

Event Type  malfunction  

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 Description

Rear locking mechanism broken off at the threads.Case type: tha.

Event Description

Rear locking mechanism broken off at the threads.Case type: tha.

Manufacturer Narrative

Reported event: it was reported that rear locking mechanism broken off at the threads.Product evaluation and results: visual inspection.Visual inspection confirms failed locking mechanism.There is oxidation and discoloration on the 202870 slide assembly, 202862 ball retainer.The 202857 dowel pin that locates the 202870 slide assembly has backed out, causing the slide assembly to rotate freely.The 206966 reamer barrell has fractures/cracks at the degree markers.The 202866 release knob is sheared off.See attachments for images of the instrument.Dimensional inspection: dimensional inspection was not completed as visual inspection clearly shows the failure of the device.Functional inspection: functional inspection was not completed as visual inspection clearly shows the failure of the device.Material analysis: material analysis was completed as part of the root cause investigation of capa 1450905 product history review: review of product history records indicate (b)(4) were manufactured and (b)(4)were accepted into final stock on 11/03/2017.Review of qt 17- 11 -0006 revealed that the non conformance is not related to the failure alleged in this complaint.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 206967, lot number 19420816 shows 14 additional complaints related to the failure in this investigation.The complaints are (b)(4).Conclusions: the failure is confirmed via visual inspection.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.Corrective action/preventive action: a review of stryker¿s nc/capa database indicated there have been an nc and capa associated with the product and failure mode reported in this event.This is nc 1414603 & capa 1450905.

• Brand Name: HIP END EFFECTOR, VARIABLE ANGLE
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9452834
• MDR Text Key: 170434583
• Report Number: 3005985723-2019-00900
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486022167
• UDI-Public: 00848486022167
• Combination Product (y/n): N
• PMA/PMN Number: K121064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 206967
• Device Catalogue Number: 206967
• Device Lot Number: 1901706
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Date Manufacturer Received: 01/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other