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

Catalog Number	209830
Medical Device Problem Codes	Fracture (1260); Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/26/2018
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
Impactor handle and impactor platform broke during impaction.Case type: tha.Surgical delay- =15 minutes.
Additional Manufacturer Narrative
Follow-up #1 and final report submitted.Product identification: the reported device was confirmed to be a trident inline offset impactor, p/n 209830, lot 32884, rma 263629.Inspection: visual inspection shows the impactor shaft broken in two separate pieces.Refer to attachment.Product history: review of device history records indicate that 8 devices were accepted into final stock on 07/07/16 with no reported discrepancies.Complaint history review: review of complaint within trackwise database for p/n 209830, lot 32884 shows 0 other complaints related to the failure in this investigation.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: part inspection confirms reported issue showing a fracture shaft in the distal end of the impactor.
Event or Problem Description
Impactor handle and impactor platform broke during impaction.Case type: tha.Surgical delay =15 minutes.

• 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: 8163877
• Report Number: 3005985723-2018-00751
• Device Sequence Number: 2266502
• Product Code: OLO
• UDI-Device Identifier: 00848486030285
• UDI-Public: 00848486030285
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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): 02/26/2019

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: 11/26/2018
• Supplement Date Received by Manufacturer: 01/29/2019
• Initial Report FDA Received Date: 12/14/2018
• Supplement Report FDA Received Date: 02/26/2019
• 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