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

Catalog Number	111640
Medical Device Problem Codes	Output Problem (3005); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	10/23/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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 or Problem 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.".
Additional 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)
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9260073
• Report Number: 3005985723-2019-00783
• Device Sequence Number: 2600555
• Product Code: OLO
• UDI-Device Identifier: 00848486001322
• UDI-Public: 00848486001322
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K112507
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 111640
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/24/2019
• Supplement Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 10/31/2019
• Supplement Report FDA Received Date: 01/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other