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

Catalog Number	209830
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	07/17/2019
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
The back part of the impaction handle broke off.Case type: tha.
Additional Manufacturer Narrative
Follow-up #1 and final report submitted.Reported event: it was reported that the back part of the impaction handle broke off.Product evaluation and results: product inspection could not be performed as the product was not available for evaluation.Capa: 2127499 has been raised for lost product.If the device is returned then the complaint will be reopened.Product history review: review of the device history records indicate 25 devices were manufactured under lot no: 32882 and accepted into final stock on 12/22/2015 and 28 of 29 devices were manufactured and accepted into final stock on 12/23/2015.The rejected device was dispositioned as "return to vendor" per qt 15-12- 0072 on (b)(6) 2016.The non conformance was unrelated to the failure in this investigation.Complaint history review: a review of complaints in catsweb and trackwise related to p/n: 209830, lot number: 32882 shows 09 additional complaints related to the failure in this investigation.The related complaint is (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.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.Capa: 2127499 has been raised for lost product.If the device is returned then the complaint will be reopened.H3 other text : product was not available for evaluation.
Event or Problem Description
The back part of the impaction handle broke off.Case type: tha.

• 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: 8864084
• Report Number: 3005985723-2019-00554
• Device Sequence Number: 11311764
• Product Code: OLO
• UDI-Device Identifier: 00848486030285
• UDI-Public: 00848486030285
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 10/01/2019

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: 32882
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/17/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 08/06/2019
• Supplement Report FDA Received Date: 10/01/2019
• 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