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

Catalog Number 160173

Device Problem Decoupling (1145)

Patient Problem No Patient Involvement (2645)

Event Date 08/06/2018

Event Type  malfunction  

Manufacturer Narrative

It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not available.

Event Description

Customer reported that the plastic part of the tibial plate impactor keeps on coming off during sterilization.

Event Description

Customer reported that the plastic part of the tibial plate impactor keeps on coming off during sterilization.

Manufacturer Narrative

Device information was corrected.An event regarding disassociation involving a mako handle was reported.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 has been one other similar event for the reported lot.Conclusion: it was reported that the plastic part of the tibial plate impactor keeps on coming off during sterilization.The device was not returned.The device was discovered during sterilization.There was no surgical procedure associated with the reported event.This event meets the definition of preventive maintenance; no further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: IMPACTOR HANDLE C
• 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: 7835188
• MDR Text Key: 118884699
• Report Number: 3005985723-2018-00517
• 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,other
• Type of Report: Initial,Followup
• Report Date: 11/29/2018

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: 160173
• Device Lot Number: 19280316
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/06/2018
• Initial Date FDA Received: 08/30/2018
• Supplement Dates Manufacturer Received: 11/01/2018
• Supplement Dates FDA Received: 11/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other