MAUDE Adverse Event Report: MAKO SURGICAL CORP. SHELL IMPACTION PLATFORM; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number	206270
Medical Device Problem Codes	Material Integrity Problem (2978); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/23/2019
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
During a mako tha procedure, cup impaction was successful and completed.Upon dismantling the mako cup inserter, the "impaction platform" was cracked and fell apart upon removal from the impactor shaft.Update: was the patient under anesthesia when the event occurred? yes.Were any debris/components left inside of the patient? no debris was left inside the patient, surgeon was happy that all debris/ parts of the broken component were accounted for.Were any components of the device missing or disassembled when the issue occurred? no, the component was complete when the issue occurred.
Additional Manufacturer Narrative
Follow-up #1 and final report submitted to update sections.Reported event: it was reported that during a mako tha procedure, cup impaction was successful and completed.Upon dismantling the mako cup inserter, the "impaction platform" was cracked and fell apart upon removal from the impactor shaft.Product evaluation and results: product inspection could not be performed as the product was not available for evaluation.Product history review of the device history records indicate 104 devices were manufactured under lot: 45010216 and accepted into final stock on 05/26/2016.No non-conformance were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n: 206270, lot: 45010216 shows 10 additional complaints related to the failure in this investigation.The complaint is pr 1703282, 1846234, 1868097, 1908295, 1951007, 1996045, 2008507, 2035552, 2082560, 2139541.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.H3 other text : product was not available for evaluation.
Event or Problem Description
During a mako tha procedure, cup impaction was successful and completed.Upon dismantling the mako cup inserter, the "impaction platform" was cracked and fell apart upon removal from the impactor shaft.Update: was the patient under anesthesia when the event occurred? yes.2.Were any debris/components left inside of the patient? no debris was left inside the patient, surgeon was happy that all debris/ parts of the broken component were accounted for.3.Were any components of the device missing or disassembled when the issue occurred? no, the component was complete when the issue occurred.

• Brand Name: SHELL IMPACTION PLATFORM
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8889030
• Report Number: 3005985723-2019-00573
• Device Sequence Number: 11586953
• Product Code: OLO
• UDI-Device Identifier: 00848486022082
• UDI-Public: 00848486022082
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K121064
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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: 206270
• Device Lot Number: LOT# 45010216
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/23/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 08/13/2019
• 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
• Patient Age: 47 YR
• Patient Weight: 87