MAUDE Adverse Event Report: MAKO SURGICAL CORP. CHECKPOINT, 3.5 HEX IMPACTION STERILE; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number 111653

Device Problems Break (1069); Material Deformation (2976)

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

Event Date 12/18/2018

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

Stryker rep reported that there was an incident regarding a checkpoint.Professor fehily performed 1x mako total hip procedures on the (b)(6) 2018.When removing the pelvic checkpoint from the patient it was retrieved incomplete with the remainder of the checkpoint pin potentially being left in the patient.No attempt was made to retrieve the remaining metal that was thought to be in the patient.

Event Description

Stryker rep reported that there was an incident regarding a checkpoint.**update** professor fehily performed 1x mako total hip procedures on the (b)(6) 2018.When removing the pelvic checkpoint from the patient it was retrieved incomplete with the remainder of the checkpoint pin potentially being left in the patient.No attempt was made to retrieve the remaining metal that was thought to be in the patient.

Manufacturer Narrative

Reported event: stryker rep reported that there was an incident regarding a checkpoint.Professor fehily performed 1x mako total hip procedures on the 18.12.2018.When removing the pelvic checkpoint from the patient it was retrieved incomplete with the remainder of the checkpoint pin potentially being left in the patient.No attempt was made to retrieve the remaining metal that was thought to be in the patient.Product evaluation and results: device unavailable for inspection.Product history review: a review of the device history records could not be performed as the lot was not provided.Complaint history review: a review of the complaint history could not be performed as the lot was not provided.Conclusions: no further investigation for this event is possible at this time as no devices and / or insufficient information was received by stryker orthopaedics.If devices and / or additional information become available, this investigation will be reopened.Corrective action/preventive action: a review of stryker¿s nc/capa database indicated there have been no ncs or capas associated with the product and failure mode reported in this event.H3 other text : product was not available for evaluation.

• Brand Name: CHECKPOINT, 3.5 HEX IMPACTION STERILE
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8205125
• MDR Text Key: 131714814
• Report Number: 3005985723-2018-00801
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486017316
• UDI-Public: 00848486017316
• 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: 03/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 111653
• Device Lot Number: TBC
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other