MAUDE Adverse Event Report: MAKO SURGICAL CORP. TIBIA INST-VITAMIN E-ONLAY SIZE4-9MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number 180744-2

Device Problems Break (1069); Degraded (1153); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/23/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During a pka procedure today, while dr.(b)(6) was trying to impact the e-poly into the tibial baseplate, the insert got damaged.He was not able to re-use it, he used a 4x9mm x3 poly instead.No adverse reactions to patient, minimal case delay, and case finished successfully.

Manufacturer Narrative

An event regarding alleged damage involving a tibial insert-vitamin e-onlay size 4-9mm was reported.The event was confirmed.Method & results: device evaluation and results: visual inspection indicated the device was returned in used condition.On one corner (edge) of the device, damage was evident: the poly material was deformed, showing pitting, burrs, scratches and scrapes.On this same corner, a strand of the poly material was frayed.The device was examined by the material analysis team.The team concluded damage to the corner of the device was consistent with impaction and forcing.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Device history review: confirmed all devices accepted into finished goods conformed to specification complaint history review: no other similar events for the reported lot.Conclusions: visual inspection indicated the device was returned in used condition.On one corner (edge) of the device, damage was evident: the poly material was deformed, showing pitting, burrs, scratches and scrapes.On this same corner, a strand of the poly material was frayed.The device was examined by the material analysis team.The team concluded damage to the corner of the device was consistent with impaction and forcing.

Event Description

During a pka procedure today, while dr.(b)(6) was trying to impact the e-poly into the tibial baseplate, the insert got damaged.He was not able to re-use it, he used a 4x9mm x3 poly instead.No adverse reactions to patient, minimal case delay, and case finished successfully.

• Brand Name: TIBIA INST-VITAMIN E-ONLAY SIZE4-9MM
• 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: 5307391
• MDR Text Key: 34575707
• Report Number: 3005985723-2015-00306
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 180744-2
• Device Lot Number: 12240814-1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other