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

Catalog Number 111651

Device Problems No Apparent Adverse Event (3189); Non Reproducible Results (4029)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/13/2019

Event Type  malfunction  

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

During a mako tka case that my colleague (b)(6) and i were running together, after all cuts were done and implants were cemented, the scrub nurse noticed that the tibial checkpoint was missing from the patient¿s tibia.Since the checkpoint could not be found anywhere, the surgeon requested an x-ray of the patient before closing the wound.At this stage, the checkpoint was found underneath the implanted tibial component, which at that point was already cemented on bone.

Event Description

During a mako tka case that my colleague shane madigan and i were running together, after all cuts were done and implants were cemented, the scrub nurse noticed that the tibial checkpoint was missing from the patient¿s tibia.Since the checkpoint could not be found anywhere, the surgeon requested an x-ray of the patient before closing the wound.At this stage, the checkpoint was found underneath the implanted tibial component (see attached x-ray picture), which at that point was already cemented on bone.

Manufacturer Narrative

Reported event: it was reported that the checkpoint was left in the patient.Product evaluation and results: the product was unavailable for inspection as the product was not returned.Product history review: product history review was not performed as the lot number was not provided.Complaint history review: complaint history review was not performed as the lot number was not provided.Conclusions: the failure could not be determined as the product was not available for inspection.No additional investigation or specific actions are 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.

• 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: 8353291
• MDR Text Key: 136604975
• Report Number: 3005985723-2019-00159
• 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: 06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 111651
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization