MAUDE Adverse Event Report: MAKO SURGICAL CORP. FEMORAL TRIAL STD LM/RL SIZE 5; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POL

Catalog Number 170505

Device Problems Break (1069); Mechanical Jam (2983); Adverse Event Without Identified Device or Use Problem (2993)

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 crack/fracture involving a femoral trial std lm/rl size 5 was reported.Conclusions: the event was confirmed that the tip of the slaphammer was stucked in the thread of the trial.However, there is no indication the trial contributed to the event.The mar concluded that, "the slaphammer tip fractured in overload.Intergranular fracture morphologies were observed on the slaphammer." there was no sign of trial fracture.There is no indication the trial contributed to the reported event.No further investigation for this event is possible at this time.If additional information become available, this investigation will be reopened.

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 STD LM/RL SIZE 5
• 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): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: brian lauro ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 6654779
• MDR Text Key: 78142096
• Report Number: 3005985723-2017-00261
• 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: 170505
• Device Lot Number: 240222K
• 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: 11/11/2015
• 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