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

Catalog Number 160405

Device Problems Material Fragmentation (1261); Naturally Worn (2988); Insufficient Information (3190)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 10/11/2016

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

Plastic tibial impactor worn.Leaving debris when impacting.

Manufacturer Narrative

Device was not returned.An event regarding wear involving an impactor-onlay insert was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as the device was not returned.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.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the instrument are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and/or additional information become available, this investigation will be reopened.Not returned to the manufacturer.

Event Description

Plastic tibial impactor worn.Leaving debris when impacting.

• Brand Name: IMPACTOR-ONLAY INSERT
• 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: 6105365
• MDR Text Key: 60551149
• Report Number: 3005738134-2016-00005
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K090763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/03/2017

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: 160405
• Device Lot Number: 12250914
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/19/2016
• Initial Date FDA Received: 11/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2014
• 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