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

Catalog Number	209830
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/11/2018
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
(b)(6) reported that "during mako total hip surgery, the doctor was installing acetabular cup prosthesis with inline offset impactor.The doctor decided that the cup was installed "for" and said he/she would blow with the mallet one last time.When the doctor hit impactor with the mallet as usual, back-end of the impactor broke.The doctor removed the impactor from the prosthesis in a typical manner, confirmed that the prosthesis was placed in the pelvis and carried the surgery on.".
Event or Problem Description
Tayfun simsek reported that "during mako total hip surgery, the doctor was installing acetabular cup prosthesis with inline offset impactor.The doctor decided that the cup was installed for and said he/she would blow with the mallet one last time.When the doctor hit impactor with the mallet as usual, back-end of the impactor broke.The doctor removed the impactor from the prosthesis in a typical manner, confirmed that the prosthesis was placed in the pelvis and carried the surgery on".
Additional Manufacturer Narrative
Product identification: the reported device was a rio®shell impact-offset-trident pst, p/n 209830, lot 32885.Inspection: visual inspection confirms facture shaft on the distal end of the impactor.Refer to attachment.Product history: review of the device history records indicate 99 devices were manufactured and accepted into final stock on (b)(6) 2016.No non-conformances were identified during inspection.Complaint history review: a review of complaints trackwise related to p/n 209830, l/n 32885 shows one (1) additional complaint related to the failure in this investigation.Pr (b)(6).Nc/capa history review: 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.Conclusion: visual inspection confirms facture shaft on the distal end of the impactor.Refer to attachment.Part inspection confirms reported issue.

• 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: 8166221
• Report Number: 3005985723-2018-00752
• Device Sequence Number: 11252969
• Product Code: OLO
• UDI-Device Identifier: 00848486030285
• UDI-Public: 00848486030285
• Combination Product (Y/N): N
• PMA/510(K) Number: K141989
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2019

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: 32885
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/12/2018
• Supplement Date Received by Manufacturer: 01/24/2019
• Initial Report FDA Received Date: 12/14/2018
• Supplement Report FDA Received Date: 02/18/2019
• 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