MAUDE Adverse Event Report: MAKO SURGICAL CORP. FEMORAL TRIAL SLAPHAMMER; INSTRUMENT

Model Number 06030813

Device Problems Fracture (1260); Insufficient Information (3190)

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

Event Date 07/22/2015

Event Type  malfunction  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was retained by the hospital and was not returned to the manufacturer.Additional information has been requested but not made available.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.

Event Description

During insertion of the femoral trial, dr.Used a mallet to strike the 111140 inserter/extractor and the threaded tip broke off inside the trial.No issues arose from this incident as dr.Was able to remove the trial by hand.I advised him that the instrument was not intended for impaction with a mallet as we provide a separate impactor in the tray.

Manufacturer Narrative

An event regarding fracture of a femoral trial slaphammer was reported.The event was not confirmed.Method & results: device evaluation could not be performed as the subject device was not returned.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there has been no other events for the lot referenced.Conclusion: the event could not be confirmed but based on the provided information, the root cause was likely due to user error as the femoral trial is intended to be impacted, not the reported slaphammer.No further investigation is possible at this time.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.

Event Description

During insertion of the femoral trial, dr.Used a mallet to strike the 111140 inserter/extractor and the threaded tip broke off inside the trial.No issues arose from this incident as dr.Was able to remove the trial by hand.I advised him that the instrument was not intended for impaction with a mallet as we provide a separate impactor in the tray.

• Brand Name: FEMORAL TRIAL SLAPHAMMER
• Type of Device: INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer (Section G): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer Contact: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5013584
• MDR Text Key: 23418287
• Report Number: 3005985723-2015-00144
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 07/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: 06030813
• Device Catalogue Number: 111140
• Device Lot Number: 06030813
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other