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

Catalog Number 160177

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/27/2018

Event Type  malfunction  

Manufacturer Narrative

If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not returned.

Event Description

The blue plastic piece for the tibial impactor broke into two pieces during impaction of the tibial baseplate implant.Case type: pka.

Event Description

The blue plastic piece for the tibial impactor broke into two pieces during impaction of the tibial baseplate implant.Case type: pka.

Manufacturer Narrative

An event regarding crack/fracture involving a mako impactor was reported.The event was confirmed through visual inspection of the image received.Method & results: device evaluation and results: visual inspection of the received image noted that the device was broken into two parts.Dimensional, functional and material analysis could not be performed as the device was not returned.Clinician review: not performed as no medical records were provided for review.Device history review: indicated that all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there has been 1 other similar event for the lot referenced.Conclusions: it was reported that blue plastic piece for the tibial impactor broke into two pieces during impaction of the baseplate implant.Visual inspection of the received image of the device noted that device was broken into two parts.The device was not returned for dimensional and material analysis.The root cause could not be determined as the device was not returned for evaluation.No further investigation for this event is possible at this time as no devices and / or insufficient information was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• 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
• MDR Report Key: 7536896
• MDR Text Key: 109011064
• Report Number: 3005985723-2018-00305
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• PMA/PMN Number: K090763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 08/15/2018

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: 12091017
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/27/2018
• Initial Date FDA Received: 05/23/2018
• Supplement Dates Manufacturer Received: 07/17/2018
• Supplement Dates FDA Received: 08/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other