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 05/24/2017

Event Type  malfunction  

Manufacturer Narrative

A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.A supplemental report will be submitted upon completion of the investigation.

Event Description

The tip of the slap hammer broke off when being used to extract the patellofemoral trial from the femur.Update: "trial could no longer be extracted with the slap hammer considering the tip was stuck in the trial.Unable to get tip out of the trial.".

Manufacturer Narrative

Additional information: device returned to manufacturer on.An event regarding "fractured tip" involving a femoral trial slaphammer was reported.The event was confirmed.Material analysis was performed and concluded 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." medical records received and evaluation: not performed as medical records were not provided for review.A device history review confirmed all devices accepted into finished goods conformed to specification.No other events were reported for the lot indicated.The investigation concluded that based on the material analysis that: the slaphammer tip fractured in overload.Intergranular fracture morphologies were observed on the slaphammer.

Event Description

The tip of the slaphammer broke off when being used to extract the patellofemoral trial from the femur.Update: "trial could no longer be extracted with the slaphammer considering the tip was stuck in the trial.Unable to get tip out of the trial.".

• 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: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6659892
• MDR Text Key: 78186277
• Report Number: 3005985723-2017-00263
• 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: company representative,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2017
• 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: 06020316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2016
• 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