MAUDE Adverse Event Report: MAKO SURGICAL CORP. TIBIAL, CHECKPOINT, STERILE; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number	111651
Medical Device Problem Codes	Output Problem (3005); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/28/2019
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
Tibial check point sheered off when removing.Case type: tha.
Additional Manufacturer Narrative
Follow-up #1 and final report submitted based on the results of investigation.Reported event: tibial check point sheered off when removing.Product evaluation and results: the product was unavailable for inspection as the product was not returned.Product history review: review of the device history records indicate 1795 devices were manufactured and accepted into final stock on 10/08/2018.No non-conformances were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 111651, l/n w60115-1 shows no additional complaints related to the failure in this investigation.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 nc and capa associated with the product and failure mode reported in this event.Product was not available for evaluation.
Event or Problem Description
Tibial check point sheered off when removing.Case type: tha.

• Brand Name: TIBIAL, CHECKPOINT, STERILE
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8955801
• Report Number: 3005985723-2019-00636
• Device Sequence Number: 2088476
• Product Code: OLO
• UDI-Device Identifier: 00848486001353
• UDI-Public: 00848486001353
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K112507
• 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): 11/26/2019

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: 111651
• Device Lot Number: W60115-1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/28/2019
• Supplement Date Received by Manufacturer: 10/30/2019
• Initial Report FDA Received Date: 09/03/2019
• Supplement Report FDA Received Date: 11/26/2019
• 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
• Patient Age: 85 YR