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

Model Number 111651

Device Problems Fracture (1260); Difficult to Remove (1528); Appropriate Term/Code Not Available (3191)

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 12/10/2019

Event Type  malfunction  

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

Tibia checkpoint was left in patient.Checkpoint became dislodged during teaming and fell into boney defect in acetabulum and could not be recovered.Case type: tha.Surgical delay: 16-30 minutes.

Manufacturer Narrative

Reported event: tibia checkpoint was left in patient.Checkpoint became dislodged during teaming and fell into bony defect in acetabulum and could not be recovered.Case type: tha.Surgical delay : 16-30 minutes.Product evaluation and results: as per the x-ray provided the checkpoint can be seen left in the patients body.Product history review: review of the device history records indicate (b)(4) were manufactured and accepted into final stock on 09/23/2019.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 w64053-2 shows no additional complaints related to the failure in this investigation.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

Tibia checkpoint was left in patient.Checkpoint became dislodged during teaming and fell into bony defect in acetabulum and could not be recovered.Case type: tha.Surgical delay : 16-30 minutes.

• Brand Name: TIBIAL, CHECKPOINT, STERILE
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9654852
• MDR Text Key: 177231566
• Report Number: 3005985723-2020-00065
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486001353
• UDI-Public: 00848486001353
• Combination Product (y/n): N
• PMA/PMN Number: K112507
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 111651
• Device Catalogue Number: 111651
• Device Lot Number: W64053-2
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 62 YR