MAUDE Adverse Event Report: MAKO SURGICAL CORP. FEMORAL TRIAL SLAPHAMMER; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number 111140

Device Problems Break (1069); Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/11/2017

Event Type  malfunction  

Manufacturer Narrative

Review of the device history records indicate the devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

Event Description

Surgeon went to insert the femoral trial and the trial inserter broke off with the threads inside the trial.The surgeon used the blue femoral impactor to finish impacting.This was for a pka procedure.

Manufacturer Narrative

An event regarding crack/fracture involving a femoral trial slaphammer was reported.The event was confirmed.Visual inspection of returned device indicated that device is broken.Functional and dimensional test couldn't be conducted since product was returned damaged and broken.Material analysis report indicated that a similar event exists.The conclusion of the material analysis stated that "the slaphammer tip fractured in overload.Intergranular fracture morphologies were observed on the slaphammer.The slaphammer met the drawing requirement for hardness.Eds showed the slaphammer was consistent with 465 ph stainless steel alloy.It is recommended look into the heat treatment and hardness requirement for the 465 ph ss slaphammer." no medical records or x-rays were made available for evaluation.Device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies there has been no other event for the lot referenced.The event was confirmed.It is reported that trial inserter broke off with the threads inside the trial.Visual inspection of returned device indicated that device is broken.Material analysis report indicated that a similar event exists.The conclusion of the material analysis stated that "the slaphammer tip fractured in overload.Intergranular fracture morphologies were observed on the slaphammer.The slaphammer met the drawing requirement for hardness.Eds showed the slaphammer was consistent with 465 ph stainless steel alloy.It is recommended look into the heat treatment and hardness requirement for the 465 ph ss slaphammer." if the additional information are received, this investigation will be reopened and re-evaluated.

Event Description

Surgeon went to insert the femoral trial and the trial inserter broke off with the threads inside the trial.The surgeon used the blue femoral impactor to finish impacting.This was for a pka procedure.

• Brand Name: FEMORAL TRIAL SLAPHAMMER
• Type of Device: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
• 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: timothy rice ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7011431
• MDR Text Key: 92535090
• Report Number: 0002249697-2017-03244
• 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: Initial,Followup
• Report Date: 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 111140
• Device Lot Number: 06030614
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2014
• 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