MAUDE Adverse Event Report: MAKO SURGICAL CORP. CHECKPOINT, 3.5MM HEX X 15MM, STERILE; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number	116230
Medical Device Problem Codes	Difficult to Remove (1528); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/24/2019
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
Checkpoint was left in patient.Doctor made this choice.Case type: tha.Surgical delay: x - =15 minutes.
Additional Manufacturer Narrative
Follow-up #1 and final report submitted based on the results of investigation.Reported event: checkpoint was left in patient.Doctor made this choice.Product evaluation and results: product inspection could not be performed as the product was not available for evaluation.Product history review: review of the device history records indicate (b)(4) devices were manufactured and accepted into final stock on 07/20/2018.No non-conformances were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 116230, l/n w58901-1 shows no additional complaints related to the failure in this investigation.Conclusions: the alleged failure mode could not be confirmed as the product was not available for inspection.No additional investigation or specific actions are required.¿if device and/or additional information become available, this investigation 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.H3 other text : device not returned.
Event or Problem Description
Checkpoint was left in patient.Doctor made this choice.Case type: tha.Surgical delay: x - =15 minutes.

• Brand Name: CHECKPOINT, 3.5MM HEX X 15MM, STERILE
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8689847
• Report Number: 3005985723-2019-00421
• Device Sequence Number: 2948055
• Product Code: OLO
• UDI-Device Identifier: 00848486002978
• UDI-Public: 00848486002978
• 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): 09/09/2019

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: 116230
• Device Lot Number: W58901-1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/24/2019
• Supplement Date Received by Manufacturer: 08/30/2019
• Initial Report FDA Received Date: 06/11/2019
• Supplement Report FDA Received Date: 09/09/2019
• 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: 80 YR