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

Catalog Number	160177
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device discarded.
Event or Problem Description
Blue plastic tip tibial impactor broke (restoris mck).After numerous cycles through an autoclave, the polymer wears out.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3005985723-2018-00486
• Device Sequence Number: 1399530
• Product Code: NPJ
• UDI-Device Identifier: 00848486003128
• UDI-Public: 00848486003128
• Combination Product (Y/N): N
• Initial Reporter Country: LU
• PMA/510(K) Number: K090763
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 160177
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/17/2018
• Supplement Date Received by Manufacturer: 09/13/2018
• Initial Report FDA Received Date: 08/14/2018
• Supplement Report FDA Received Date: 10/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other