MAUDE Adverse Event Report: MAKO SURGICAL CORP. FEMORAL/TIBIAL CHECKPOINT KIT -(STERILE); STEREOTAXIC DEVICE, ROBOTICS

Catalog Number	111645
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/07/2019
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
The surgeon texted me in the evening after the surgery.He said that the check points had been left in the patient.I responded that my practice was always to remind the operative staff to remove checkpoints.The following day, the surgeon told me that he had decided to leave the checkpoints in the patient and only remove them if there was a problem.He said the patient was not upset about it and the surgeon didn't blame me for the incident.The hospital orthopedic coordinator told the surgeon that the checkpoints were definitely part of the official count, so the nurse and tech in the room should have caught it, as well as the physician's assistant and surgeon.There have been no repercussions from any party for this incident to date.Case type: pka.
Additional Manufacturer Narrative
Reported event: the surgeon texted me in the evening after the surgery.He said that the check points had been left in the patient.I responded that my practice was always to remind the operative staff to remove checkpoints.The following day, the surgeon told me that he had decided to leave the checkpoints in the patient and only remove them if there was a problem.He said the patient was not upset about it and the surgeon didn't blame me for the incident.The hospital orthopedic coordinator told the surgeon that the checkpoints were definitely part of the official count, so the nurse and tech in the room should have caught it, as well as the physician's assistant and surgeon.Product evaluation and results: product inspection was not performed as product was not available for inspection.Product history review: review of the device history records indicate 1000 devices were manufactured and accepted into final stock on 11/19/2018.No non-conformances were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 111645, l/n 11192018-3 shows no additional complaints related to the failure in this investigation.Conclusions: the failure mode could not be confirmed because the part was not available for evaluation.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.
Event or Problem Description
The surgeon texted me in the evening after the surgery.He said that the check points had been left in the patient.I responded that my practice was always to remind the operative staff to remove checkpoints.The following day, the surgeon told me that he had decided to leave the checkpoints in the patient and only remove them if there was a problem.He said the patient was not upset about it and the surgeon didn't blame me for the incident.The hospital orthopedic coordinator told the surgeon that the checkpoints were definitely part of the official count, so the nurse and tech in the room should have caught it, as well as the physician's assistant and surgeon.There have been no repercussions from any party for this incident to date.Case type: pka.

• Brand Name: FEMORAL/TIBIAL CHECKPOINT KIT -(STERILE)
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8645337
• Report Number: 3005985723-2019-00391
• Device Sequence Number: 1654648
• Product Code: OLO
• UDI-Device Identifier: 00848486029494
• UDI-Public: 00848486029494
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K143752
• 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: 111645
• Device Lot Number: 11192018-3
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/16/2019
• Supplement Date Received by Manufacturer: 08/30/2019
• Initial Report FDA Received Date: 05/28/2019
• 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