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

Catalog Number 111645

Device Problems Mechanical Problem (1384); Use of Device Problem (1670)

Patient Problems Discomfort (2330); No Known Impact Or Consequence To Patient (2692)

Event Date 06/29/2017

Event Type  Injury  

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 Description

On (b)(6) 2017 a pfj was conducted with the mako at (b)(6).At the beginning of the case i notified staff that all bone pins and checkpoints were to be included in the count.During the surgery i notified the surgeon to use a ronguer to remove the checkpoint as he was removing the bone pins.At the end of the case i asked if the count was correct and was told that it was correct by the nursing staff.The following day on (b)(6) 2017 the recon rep notified me that a femur checkpoint was found in a post op x-ray inside the patient.On (b)(6) 2017 the surgeon performed an additional procedure opening the incision to remove the checkpoint.The checkpoint was removed and an additional x-ray was taken.It showed complete removal of the checkpoint.Case type: mako pfj.Application pka.

Manufacturer Narrative

Reported event: the surgeon left the femoral checkpoint in the patient and additional surgery was performed to remove the femoral checkpoint.Device evaluation and results: the checkpoint was not returned.The issue in this complaint was not a product defect but a use error.Device history review: review of the device history record shows no non-conformances for the parts.Complaint history review: a review of complaints within the trackwise database for p/n 111645 for p/n 111645 show one other complaint related to the failure in this investigation.The pr is (b)(4).Conclusion: the surgeon left the checkpoints in the patient even with the on-screen warning and user guide warnings.There were no device issues.No additional investigation is required.Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.The device was not returned for evaluation.

Event Description

On (b)(6) 2017 a pfj was conducted with the mako at (b)(6) hospital in (b)(6).At the beginning of the case i notified staff that all bone pins and checkpoints were to be included in the count.During the surgery i notified the surgeon to use a rongeur to remove the checkpoint as he was removing the bone pins.At the end of the case i asked if the count was correct and was told that it was correct by the nursing staff.The following day on (b)(6) 2017 the recon rep notified me that a femur checkpoint was found in a post op x-ray inside the patient.On (b)(6) 2017 the surgeon performed an additional procedure opening the incision to remove the checkpoint.The checkpoint was removed and an additional x-ray was taken.It showed complete removal of the checkpoint.Case type: mako pfj.Update 07/10/2017: application pka.

• Brand Name: CHECKPOINT KIT, STERILE
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer (Section G): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer Contact: bethany hinson ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 6735683
• MDR Text Key: 80785180
• Report Number: 3005985723-2017-00333
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112507
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 111645
• Device Lot Number: 03042016-1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/29/2017
• Initial Date FDA Received: 07/24/2017
• Supplement Dates Manufacturer Received: 07/30/2017
• Supplement Dates FDA Received: 08/07/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 44 YR
• Patient Weight: 270