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

Catalog Number 111140

Device Problems Break (1069); Detachment Of Device Component (1104); Sticking (1597)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 05/23/2017

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

During impaction of the size 5 lm femur trial, the slap hammer threads broke off into the trial.The slap hammer is broken, as well as the femur trial (tip of slap hammer stuck inside where it normally threads on to).

Manufacturer Narrative

An event regarding "fractured tip" involving a femoral trial slaphammer was reported.The event was confirmed.Device evaluation and results: examination of the returned device indicated the fracture surface was consistent with previously completed material analyses for the same product and issue.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.Device history review: a device history review confirmed all devices accepted into finished goods conformed to specification.Complaint history review: no other events were reported for the lot indicated.Conclusions: 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

During impaction of the size 5 lm femur trial, the slap hammer threads broke off into the trial.The slap hammer is broken, as well as the femur trial (tip of slap hammer stuck inside where it normally threads on to.

• Brand Name: FEMORAL TRIAL SLAPHAMMER
• Type of Device: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POL
• 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: 6654765
• MDR Text Key: 78158956
• Report Number: 3005985723-2017-00260
• 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
• Reporter Occupation: Other
• 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: 06/20/2017
• 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: 6030614
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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