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	11/12/2018
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
During impaction, shaft and platform both broke.Surgical delay: 15 minutes.Case type: tha.
Event or Problem Description
During impaction, shaft and platform both broke.Surgical delay- =15 minutes.Case type: (b)(4).
Additional Manufacturer Narrative
Follow-up #1 and final report submitted.Reported event: it was reported that the impactor broke during impaction.Product evaluation and results: the product was not evaluated as the product was unavailable for inspection.Product history review: review of the product history records indicate (b)(4) devices were manufactured under lot 32405 and accepted into final stock on 11/17/ 2015.No non-conformances were identified during inspection.History review: complaint history review: a review of complaints in catsweb and trackwise related to p/n 209820, lot number 32405 shows no additional complaints related to the failure in this investigation.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.Corrective action/preventive action: 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: 8135094
• Report Number: 3005985723-2018-00719
• Device Sequence Number: 2056817
• 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): 05/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Catalogue Number: 209820
• Device Lot Number: 32405
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/12/2018
• Supplement Date Received by Manufacturer: 04/30/2019
• Initial Report FDA Received Date: 12/05/2018
• 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