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); Insufficient Information (3190)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 10/03/2016

Event Type  malfunction  

Manufacturer Narrative

Additional information has been requested.Should additional information become available, it will be reported in a supplemental report upon completion of the investigation.

Event Description

Damaged while impacting the baseplate.

Manufacturer Narrative

A correction was made as the device was not returned to the manufacturer.An event regarding crack/fracture involving an mako impactor was reported.The event was not confirmed.Method & results: device evaluation and results: a visual, functional and dimensional inspection could not be performed as the device was not returned.Medical records received and evaluation: not performed as patient factors did not contribute to the event.Device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there have been no other event for the lot referenced.Conclusions: the event was not confirmed nor the root cause determined because the device was not returned for evaluation and insufficient information was provided.If the device and/or additional information is received, this investigation will be reopened and re-evaluated.Not returned to the manufacturer.

Event Description

Damaged while impacting the baseplate.

• 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: joann lavatelli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6064441
• MDR Text Key: 59036760
• Report Number: 3005738134-2016-00001
• 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: 01/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 12030411
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/03/2016
• Initial Date FDA Received: 10/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2011
• 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