MAUDE Adverse Event Report: MAKO SURGICAL CORP. RIO®SHELL IMPACT-OFFSET-TRIDENT PST; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number	209830
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/02/2019
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
While taking off strike plate piece of impaction handle broke off.Case type: tha.Update: patient was under anesthesia.Were any debris/components left inside of the patient? "no".Were any components of the device missing or disassembled when the issue occurred? "no".
Additional Manufacturer Narrative
Reported event: it was reported that ¿while taking off strike plate piece of impaction handle broke off¿.Product evaluation and results: visual inspection visual inspection of the provided photos conform crack/fracture of the rio®shell impact-offset-trident pst device.Dimensional inspection, functional inspection and material analysis was not completed as the device was unavailable for for evaluation.Product history review: review of the product history records indicate (b)(4) devices were manufactured under lot no 32884 and accepted into final stock on 07/07/2016.No non-conformances were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 209830, lot number 32884, shows 02 additional complaints related to the failure in this investigation.Complaint investigation(s) (b)(4).Conclusions: the failure was conformed through visual inspection of the provided photos.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 no ncs or capas associated with the product and failure mode reported in this event.
Event or Problem Description
While taking off strike plate piece of impaction handle broke off.Case type: tha.Update: patient was under anesthesia.Were any debris/components left inside of the patient? "no".Were any components of the device missing or disassembled when the issue occurred? "no".

• Brand Name: RIO®SHELL IMPACT-OFFSET-TRIDENT PST
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8786430
• Report Number: 3005985723-2019-00507
• Device Sequence Number: 1999115
• Product Code: OLO
• UDI-Device Identifier: 00848486030285
• UDI-Public: 00848486030285
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 09/17/2019

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: 209830
• Device Lot Number: 32884
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/02/2019
• Supplement Date Received by Manufacturer: 09/14/2019
• Initial Report FDA Received Date: 07/12/2019
• Supplement Report FDA Received Date: 09/17/2019
• 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