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

Catalog Number 160195

Device Problems Break (1069); Fracture (1260); Positioning Problem (3009)

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

Event Date 09/30/2016

Event Type  malfunction  

Manufacturer Narrative

When completed, the investigation results will be submitted in a supplemental report.

Event Description

Plastic tip on tibial impactor broke and surgeon felt they could not fully seat the baseplate causing us to use three total 3x8 poly's update per sales rep on 10/14/2016: the impactor broke while they were impacting the insert into the baseplate.Surgeon didn't feel the baseplate was seated correctly.Insert became damaged so surgeon repositioned baseplate and used a new insert to implant.Surgeon had difficulty implanted 2nd insert and it became damaged.Surgeon again repositioned baseplate and implanted a 3rd insert and surgery was completed successfully.

Manufacturer Narrative

Additional/corrected information has been provided.Reported event: an event regarding crack/fracture involving an mako impactor head 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 has been no other event for the lot referenced.Conclusions: neither the event was confirmed nor the root cause could be 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.Product surveillance will continue to monitor for trends.Not returned to the manufacturer.

Event Description

Plastic tip on tibial impactor broke and surgeon felt they could not fully seat the baseplate causing us to use three total 3x8 poly's.Update per sales rep on 10/14/2016: the impactor broke while they were impacting the insert into the baseplate.Surgeon didn't feel the baseplate was seated correctly.Insert became damaged so surgeon repositioned baseplate and used a new insert to implant.Surgeon had difficulty implanted 2nd insert and it became damaged.Surgeon again repositioned baseplate and implanted a 3rd insert and surgery was completed successfully.

• Brand Name: INLAY IMPACTOR TIBIAL INSERT ASSY
• 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: jadwiga degrado ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6063739
• MDR Text Key: 59025826
• Report Number: 3005985723-2016-00345
• 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: 01/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 160195
• Device Lot Number: 06031208
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2008
• 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
• Patient Age: 81 YR