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 04/18/2018

Event Type  malfunction  

Manufacturer Narrative

Additional information has been requested and if received will be provided in a supplemental report.Not returned.

Event Description

It was reported that the surgeon was impacting the final tibial baseplate in using the tibial impactor and the blue tip on the impactor chipped off.They were able to remove the single piece that broke off onto the sterile field with ease.Inspected the incision for other pieces.The surgery was completed successfully using coban wrap at the tip of the impactor to prevent metal on metal contact.Pka case.

Manufacturer Narrative

An event regarding crack/ fracture involving a mako impactor was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned.Medical records received and evaluation: 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 no other similar event for the lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Additional information, including operative reports and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

Event Description

It was reported that the surgeon was impacting the final tibial baseplate in using the tibial impactor and the blue tip on the impactor chipped off.They were able to remove the single piece that broke off onto the sterile field with ease.Inspected the incision for other pieces.The surgery was completed successfully using coban wrap at the tip of the impactor to prevent metal on metal contact.Pka case.

• 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: 7519480
• MDR Text Key: 108495762
• Report Number: 3005985723-2018-00295
• 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: 07/24/2018

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 Expiration Date: 05/31/2021
• Device Catalogue Number: 160177
• Device Lot Number: 19070715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/18/2018
• Initial Date FDA Received: 05/16/2018
• Supplement Dates Manufacturer Received: 06/26/2018
• Supplement Dates FDA Received: 07/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other