MAUDE Adverse Event Report: MAKO SURGICAL CORP. TIBIAL INLAY IMPACTOR HEAD; KNEE JOINT PATELLOFEMOROTIBIAL POLYMER/METAL/POLYMER SEMI-CONSTRAINED CEMENTED P

Catalog Number 160177

Device Problems Crack (1135); Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/19/2018

Event Type  malfunction  

Manufacturer Narrative

A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

Event Description

Blue piece on the baseplate impactor.No adverse consequences as we just opened another one.The blue piece on the tibial baseplate impactor cracked and broke off during impaction.

Manufacturer Narrative

Reported event: an event regarding crack/fracture involving a mako impactor was reported.The event was confirmed through visual inspection of the provided photographs.Method & results: product evaluation and results: no product was returned for inspection however two photographs were provided for review.The photographs show the blue section/foot with lot catalog number 160177 and lot code 19060715 fractured off the tibial impactor.Damage is visible on the on the blue foot attachment.Clinician review: no medical records were received for review with a clinical consultant.Product history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been two other similar events for the lot referenced.(b)(4) & (b)(4) relates to crack/fracture.Conclusion: an event regarding crack/fracture of a mako impactor was reported.No product was returned for inspection however two photographs were provided for review.The photographs show the blue section/foot with lot catalog number 160177 and lot code 19060715 fractured off the tibial impactor.Damage is visible on the on the blue foot attachment.The exact cause of the event cannot be confirmed as insufficient information was provided.Further information such as product return and images of the device taken when the event occurred are required to complete the investigation for determining a root cause.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Blue piece on the baseplate impactor.No adverse consequences as we just opened another one.The blue piece on the tibial baseplate impactor cracked and broke off during impaction.

• Brand Name: TIBIAL INLAY IMPACTOR HEAD
• Type of Device: KNEE JOINT PATELLOFEMOROTIBIAL POLYMER/METAL/POLYMER SEMI-CONSTRAINED CEMENTED P
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8169194
• MDR Text Key: 130492659
• Report Number: 3005985723-2018-00756
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 03/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2018
• 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: 19060715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other