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

Catalog Number	206967
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/15/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
At the end of the case, found out that the collar of the handpiece broke off.Case type: tha.Update: the collar at the end of end effector broke off.Update: no debris left in patient & nothing missing.
Additional Manufacturer Narrative
Follow-up #1 and final report submitted.Reported event: it was reported that at the end of the case, found out that the collar of the handpiece broke off.Product evaluation and results: visual inspection: visual inspection confirms failed locking mechanism.The dowel pin that holds the slide assembly has backed out and the slide assembly now freely rotates.The dowel pin on the side that attaches the reamer barrell is protruding.There is oxidation and discoloration on the 202870 slide assembly, 202862 ball retainer.The 206966 reamer barrell has fractures at the degree markers.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 as 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 the device history records indicate 43 devices were manufactured under lot: 19380816 and accepted into final stock on 02/11/2017.No non conformances were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n: 206967, lot number: 19380816 shows 8 additional complaints related to the failure in this investigation.The related complaints are (b)(4).Conclusions: the alleged failure mode was confirmed.Corrective action/preventive action: a review of stryker¿s nc/capa database indicated there have been an ncs and capas associated with the product and failure mode reported in this event.This is nc: 1414603 and capa: 1450905.
Event or Problem Description
At the end of the case, found out that the collar of the handpiece broke off.Case type: tha.Update: the collar at the end of end effector broke off.Update: no debris left in patient & nothing missing.

• Brand Name: HIP END EFFECTOR, VARIABLE ANGLE
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8828204
• Report Number: 3005985723-2019-00535
• Device Sequence Number: 3011709
• Product Code: OLO
• UDI-Device Identifier: 00848486022167
• UDI-Public: 00848486022167
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 09/25/2019

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: 206967
• Device Lot Number: 1938016 / 1901662
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/15/2019
• Supplement Date Received by Manufacturer: 09/18/2019
• Initial Report FDA Received Date: 07/25/2019
• Supplement Report FDA Received Date: 09/25/2019
• 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
• Patient Age: 66 YR
• Patient Weight: 76