MAUDE Adverse Event Report: MAKO SURGICAL CORP. RIO® STRAIGHT SHELL IMPACTOR,TRIDENT PST; STEREOTAXIC DEVICE, ROBOTICS

Model Number	209820
Medical Device Problem Codes	Break (1069); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/30/2019
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
During impaction, physician was unable to lock platform into place.Upon closer inspection, found straight impactor to be broken.Case type: tha.
Event or Problem Description
During impaction, physician was unable to lock platform into place.Upon closer inspection, found straight impactor to be broken.Case type: tha.
Additional Manufacturer Narrative
It was reported that "during impaction, physician was unable to lock platform into place.Upon closer inspection, found straight impactor to be broken." the event was confirmed.Method & results: -device evaluation and results: not performed as no items were returned.-product history review: review of the device history records indicates 97 device(s) were manufactured and accepted into final stock on 7-21-2016 with no reported discrepancies.-complaint history review: a review of complaints in catsweb and trackwise related to p/n 209820, lot 32881 shows 02 additional complaint(s) related to the failure in this investigation.Conclusion: the exact cause of the event could not be determined because the product was not received.No further investigation for this event is possible at this time as no devices and / or insufficient information was received by stryker orthopaedics or investigator.If devices and / or additional information become available, this investigation will be reopened.

• Brand Name: RIO® STRAIGHT SHELL IMPACTOR,TRIDENT PST
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9151434
• Report Number: 3005985723-2019-00716
• Device Sequence Number: 3046464
• Product Code: OLO
• UDI-Device Identifier: 00848486030278
• UDI-Public: 00848486030278
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K141989
• 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): 01/27/2020

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 Model Number: 209820
• Device Catalogue Number: 209820
• Device Lot Number: 32881
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 12/29/2019
• Initial Report FDA Received Date: 10/03/2019
• Supplement Report FDA Received Date: 01/27/2020
• 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