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

Catalog Number 111645

Device Problems Break (1069); Device Slipped (1584)

Patient Problems Deposits (1809); No Known Impact Or Consequence To Patient (2692)

Event Date 10/03/2019

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

At (b)(6) hospital with mr (b)(6), while removing tibial checkpoint following a mako tka the tip of the checkpoint broke off into the patients cortical bone.Approximately 3-5 mm remains in situ in the patients tibial tuberosity.Right mako triathlon.Tip of the tibial checkpoint remains in the patients bone.

Manufacturer Narrative

Reported event: at (b)(6) hospital with (b)(6), while removing tibial checkpoint following a mako tka the tip of the checkpoint broke off into the patients cortical bone.Approximately 3-5 mm remains in situ in the patients tibial tuberosity.Right mako triathlon tip of the tibial checkpoint remains in the patients bone.Product evaluation: the product was not returned and available for evaluation.Product evaluation and results: product inspection could not be performed as the product was not available for evaluation.Product history review: product history review was not performed as the lot number was incorrect.Complaint history review: complaint history review was not performed as the lot number was product history review was not performed as the lot number was incorrect.Conclusions: the failure could not be confirmed as the product was not returned.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.H3 other text : device not returned.

Event Description

At (b)(6) hospital with (b)(6), while removing tibial checkpoint following a mako tka the tip of the checkpoint broke off into the patients cortical bone.Approximately 3-5 mm remains in situ in the patients tibial tuberosity.Right mako triathlon tip of the tibial checkpoint remains in the patients bone.

• Brand Name: FEMORAL/TIBIAL CHECKPOINT KIT -(STERILE)
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9191238
• MDR Text Key: 167130053
• Report Number: 3005985723-2019-00735
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486029494
• UDI-Public: 00848486029494
• Combination Product (y/n): N
• PMA/PMN Number: K143752
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 111645
• Device Lot Number: 02272019-4
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 72 YR
• Patient Weight: 65