MAUDE Adverse Event Report: MAKO SURGICAL CORP. TIBIAL INLAY IMPACTOR HEAD; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number 160177

Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978); Insufficient Information (3190)

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

Event Date 02/02/2017

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted if additional information becomes available.

Event Description

The impactor head on the tibial baseplate impactor cracked and plastics pieces were starting to fall off.The issues happened when the tibial baseplate was going to be impacted and it was noticed that plastic tip was cracked on the impactor.

Manufacturer Narrative

An event regarding crack/fracture involving an mako impactor was reported.The event was confirmed.Method & results: device evaluation and results: material analysis of the returned device was performed which concluded that "the impactor head fractured in overload.No material or manufacturing defects were observed on the surfaces examined." medical records received and evaluation: not performed as medical records were not received and patient factors didn't contribute to the event.Device history review: indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there has been 1 other event for the lot referenced.Conclusions: the reported event was confirmed as per material analysis performed on the returned device which concluded that the impactor head was fractured and it was fractured in overload.No material or manufacturing defects were observed on the surfaces examined.No further investigation for this event is possible at this time.If additional information will be received, this investigation will be reopened and re-evaluated.

Event Description

The impactor head on the tibial baseplate impactor cracked and plastics pieces were starting to fall off.The issues happened when the tibial baseplate was going to be impacted and it was noticed that plastic tip was cracked on the impactor.

• Brand Name: TIBIAL INLAY IMPACTOR HEAD
• 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: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6300482
• MDR Text Key: 66481940
• Report Number: 3005985723-2017-00048
• 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: 05/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 160177
• Device Lot Number: 19050814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/08/2015
• 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