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

Catalog Number	209820
Medical Device Problem Codes	Break (1069); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/28/2018
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
End of impaction handle sheared off during impaction - impacted the cup and when the arm was taken away from the patient and the impaction platform taken off the impaction handle, part of the impaction handle had been sheared off and fell out of the impaction platform onto the sterile back table.Case type: tha.
Event or Problem Description
End of impaction handle sheared off during impaction - impacted the cup and when the arm was taken away from the patient and the impaction platform taken off the impaction handle, part of the impaction handle had been sheared off and fell out of the impaction platform onto the sterile back table.Case type: tha.
Additional Manufacturer Narrative
Follow-up #1 and final report submitted.Reported event: the event reported that a trident straight cup impactor broke during impaction.Product inspection: the product was unavailable for inspection as the product was not returned.Product history review: review of the device history records indicate 87 devices were manufactured and accepted into final stock on 10/19/2016.No non-conformances were identified during inspection.Complaint history review: review of complaints for p/n 209820, l/n 32880 within the trackwise database show no other related complaints.Nc/capa history review: a review of stryker¿s nc/capa database indicated there have been zero ncs or capas associated with the product and failure mode reported in this event.Conclusion: a review of stryker¿s nc/capa database indicated there have been no nc and capa associated with the product and failure mode reported in this event.Device not returned.

• 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: 8211778
• Report Number: 3005985723-2019-00013
• Device Sequence Number: 13959593
• Product Code: OLO
• UDI-Device Identifier: 00848486030278
• UDI-Public: 00848486030278
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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): 05/09/2019

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: 209820
• Device Lot Number: 32880
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/28/2018
• Supplement Date Received by Manufacturer: 04/30/2019
• Initial Report FDA Received Date: 01/03/2019
• Supplement Report FDA Received Date: 05/09/2019
• 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