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

Catalog Number 160177

Device Problems Material Deformation (2976); Material Integrity Problem (2978); Scratched Material (3020); Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/16/2017

Event Type  malfunction  

Manufacturer Narrative

Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Event Description

The blue piece on the tibial baseplate impactor kept falling off while impacting so the doctor wanted a new piece.

Manufacturer Narrative

An event regarding damage involving a mako impactor was reported.The event was confirmed.Method and results: device evaluation and results: the device was returned in used condition.There are scratches and gouges on the bottom and sides of the impactor.Examination of the returned device with material analysis engineer noted that damage is consistent with in-service use.Medical records received and evaluation: not performed as patient factors did not 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 no other event for the lot referenced.Conclusions: visual inspection shows the impactor was damaged.Examination of the returned device with material analysis engineer noted that damage is consistent with in-service use.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 blue piece on the tibial baseplate impactor kept falling off while impacting so the doctor wanted a new piece.

• 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6261065
• MDR Text Key: 65210711
• Report Number: 3005985723-2017-00024
• 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: 04/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2017
• 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: 12060416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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