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); Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/23/2019
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
Back of straight impaction handle sheared off during impaction.Case type: tha.
Additional Manufacturer Narrative
It was reported that back of straight impaction handle sheared off during impaction.Product evaluation and results: not performed as no items were returned.Product history review: review of the device history records indicate (b)(4) devices were manufactured and accepted into final stock on 10/19/2016 with no reported discrepancies.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 209820, lot 32880 shows 3 additional complaints related to the failure in this investigation.The complaints are (b)(4).Conclusions: the failure could not be determined as the product was not available for inspection.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.
Event or Problem Description
Back of straight impaction handle sheared off during impaction.Case type: tha.

• 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: 9260160
• Report Number: 3005985723-2019-00787
• Device Sequence Number: 19765914
• Product Code: OLO
• UDI-Device Identifier: 00848486030278
• UDI-Public: 00848486030278
• Combination Product (Y/N): N
• 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): 01/28/2020

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: 32880
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/23/2019
• Supplement Date Received by Manufacturer: 12/31/2019
• Initial Report FDA Received Date: 10/31/2019
• Supplement Report FDA Received Date: 01/28/2020
• 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