MAUDE Adverse Event Report: MAKO SURGICAL CORP. BONE PIN-4 X 170MM-STERILE (2 PACK); STEREOTAXIC DEVICE, ROBOTICS

Catalog Number 111640

Device Problems Output Problem (3005); Insufficient Information (3190)

Patient Problem Bone Fracture(s) (1870)

Event Date 10/23/2019

Event Type  Injury  

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

Femur fracture at pin site.Update 24/october/2019 as reported in adverse consequences details: "surgery to fix fracture".Rep reported the primary surgery was "mako pka using 4.0 x 170 pins.".

Event Description

Femur fracture at pin site.Update 24/october/2019 wg: as reported in adverse consequences details: "surgery to fix fracture".Rep reported the primary surgery was "mako pka using 4.0 x 170 pins.".

Manufacturer Narrative

Follow-up #1 and final report submitted to update based on the results of investigation.Femur fracture at pin site.Update 24/october/2019 wg: as reported in adverse consequences details: "surgery to fix fracture".Rep reported the primary surgery was "mako pka using 4.0 x 170 pins." product evaluation and results: product inspection could not be performed as the product was not returned for evaluation.Product history review: product history review was not conducted as lot number is not provided.Complaint history review: complaint history review was not conducted as lot number is not provided.Conclusions: the alleged 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.

• Brand Name: BONE PIN-4 X 170MM-STERILE (2 PACK)
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9260073
• MDR Text Key: 164444377
• Report Number: 3005985723-2019-00783
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486001322
• UDI-Public: 00848486001322
• Combination Product (y/n): N
• PMA/PMN Number: K112507
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 111640
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/24/2019
• Initial Date FDA Received: 10/31/2019
• Supplement Dates Manufacturer Received: 12/17/2019
• Supplement Dates FDA Received: 01/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other