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); Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	09/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As part of the 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
Broke while impacting.Case type: tha.Surgical delay: 16-30 minutes.
Event or Problem Description
Broke while impacting.Case type: tha.Surgical delay: 16-30 minutes.
Additional Manufacturer Narrative
It was reported that impactor broke while impacting case type: tha.Surgical delay: 16-30 minutes.Product evaluation and results: visual inspection: the 209830 rio shell impact-offset-trident pst (lot 33852) shows wear and tear with nicks, dings, scratches and burnish marks on the housing and shaft.The shell threaded interface is in good shape.The u-joint is burnished inside the housing.The end of the shaft (interface for the 206270 shell impaction platform) was broken off.A picture of the shaft is attached.Functional inspection: the 209830 rio shell impact-offset-trident pst (lot 33852) easily slides into a known good 206967 hip end effector, variable angle, and locks.A known good 206270 shell impaction platform could not go onto the shaft or lock onto the 209830 rio shell impact-offset-trident pst (lot 33852) because of the broken shaft.The knob turns easily.The threaded interface easily accepts an implant.The failure mode ¿broke while impacting¿ was confirmed.Dimensional inspection: not completed as failure was confirmed through visual inspection¿ material analysis: not performed as no material failure is alleged.Product history review: review of the device history records indicate 101 devices were manufactured under lot 33852 and accepted into final stock on 10/21/2016.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 33852 shows 2 additional complaints related to the failure in this investigation.Conclusions: the failure is confirmed via visual inspection.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.

• 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: 9132620
• Report Number: 3005985723-2019-00700
• Device Sequence Number: 16924909
• Product Code: OLO
• UDI-Device Identifier: 00848486030285
• UDI-Public: 00848486030285
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 12/20/2019

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: 33852
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2019
• Initial Date Received by Manufacturer: 09/20/2019
• Supplement Date Received by Manufacturer: 11/26/2019
• Initial Report FDA Received Date: 09/29/2019
• Supplement Report FDA Received Date: 12/20/2019
• 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