MAUDE Adverse Event Report: MAKO SURGICAL CORP. UNKNOWN 111653 FEMORAL CHECKPOINT; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number UNK_OFL

Device Problems Difficult to Remove (1528); Appropriate Term/Code Not Available (3191)

Patient Problems Injury (2348); Foreign Body In Patient (2687)

Event Date 12/18/2019

Event Type  Injury  

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 Description

Tha surgery was performed using mako.Prior to pelvic registration, impact driver was used to place a pelvic checkpoint screw on the illiac above the acetabulum.As a result, screw penetrated the bone and embedded on the extra-abdominal pelvis.For a while, surgeon tried to remove the screw using inoperative images, but it was difficult to remove with that approach.Surgeon decided to continue procedure without removing the screw.Will perform a ct scan and determine whether to remove the screw.

Manufacturer Narrative

Reported event: tha surgery was performed using mako.Prior to pelvic registration, impact driver was used to place a pelvic checkpoint screw on the illiac above the acetabulum.As a result, screw penetrated the bone and embedded on the extra-abdominal pelvis.For a while, surgeon tried to remove the screw using inoperative images, but it was difficult to remove with that approach.Surgeon decided to continue procedure without removing the screw.Will perform a ct scan and determine whether to remove the screw.Product evaluation and results: as per the x-ray provided the checkpoint can be seen left in the patients body.Product history review: product history review cannot be conducted as the lot number is not provided.Complaint history review: complaint history review cannot be conducted as the lot number is not provided.Conclusions: the failure of checkpoint left in patient body can be confirmed from the x- ray provided in the communication log, there is no failure of the device.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 that there have been no nc¿s associated with the product and failure mode reported in this event.

Event Description

Tha surgery was performed using mako.Prior to pelvic registration, impact driver was used to place a pelvic checkpoint screw on the illiac above the acetabulum.As a result, screw penetrated the bone and embedded on the extra-abdominal pelvis.For a while, surgeon tried to remove the screw using inoperative images, but it was difficult to remove with that approach.Surgeon decided to continue procedure without removing the screw.Will perform a ct scan and determine whether to remove the screw.

• Brand Name: UNKNOWN 111653 FEMORAL CHECKPOINT
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9594226
• MDR Text Key: 175447607
• Report Number: 3005985723-2020-00035
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 04/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_OFL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention