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

Model Number 111653

Device Problem Fracture (1260)

Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)

Event Date 11/18/2019

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

Checkpoint broke upon attempt to remove from patient acetabulum.Threaded portion of checkpoint left in patient.Case type: tha.

Manufacturer Narrative

Reported event: checkpoint broke upon attempt to remove from patient acetabulum.Threaded portion of checkpoint left in patient.Product evaluation and results: product inspection was not performed as product was not returned for inspection.Product history review: review of the device history records could not be conducted as the lot number is not provided.Complaint history review: complaint history review was not conducted as lot number is not provided.Conclusions: the failure mode could not be confirmed as the product was not available for inspection.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.H3 other text: device not returned.

Event Description

Checkpoint broke upon attempt to remove from patient acetabulum.Threaded portion of checkpoint left in patient.Case type: tha.

• 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: 9476196
• MDR Text Key: 170980384
• Report Number: 3005985723-2019-00903
• 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: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 111653
• Device Catalogue Number: 111653
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/18/2019
• Initial Date FDA Received: 12/16/2019
• Supplement Dates Manufacturer Received: 01/22/2020
• Supplement Dates FDA Received: 02/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR