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 Break (1069); Fracture (1260)

Patient Problem No Patient Involvement (2645)

Event Date 07/17/2018

Event Type  malfunction  

Manufacturer Narrative

If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device discarded.

Event Description

Blue plastic tip tibial impactor broke (restoris mck).After numerous cycles through an autoclave, the polymer wears out.

Manufacturer Narrative

It was reported that the blue plastic tip tibial impactor broke.The device was not returned.Visual inspection of the available image of the device noted that the device was fractured in two parts.The device was discovered after the pka procedure.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.

Event Description

Blue plastic tip tibial impactor broke (restoris mck).After numerous cycles through an autoclave, the polymer wears out.

• 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: 7780605
• MDR Text Key: 117285372
• Report Number: 3005985723-2018-00486
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 00848486003128
• UDI-Public: 00848486003128
• 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: 10/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2018
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other