MAUDE Adverse Event Report: MAKO SURGICAL CORP. IMP DEMAYO KNEE POSITIONER-25" (SPARE); STEREOTAXIC DEVICE, ROBOTICS

Catalog Number 110580

Device Problem Crack (1135)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 11/18/2019

Event Type  malfunction  

Manufacturer Narrative

As part of the normal complaint follow-up, an evaluation of the event has been initiated by mako surgical.A supplemental report will be submitted when additional information becomes available.

Event Description

The green demayo boot has cracks in it.Concern for bioburden.Case type: tka.

Manufacturer Narrative

Reported event: the green demayo boot has cracks in it.Concern for bioburden.Case type: tka.Product evaluation and results: the product was not evaluated as the product was unavailable for inspection capa 2127499 has been raised for the same.Product history review: product history review cannot be conducted as lot number is not provided and imp demayo knee positioner-25" (spare) is a oem product.Complaint history review: complaint history review cannot be conducted since lot number is not provided.Conclusions: per d03391, preventive maintenance is where an action occurs that identifies device deterioration which may compromise function.Under pm conditions no patient was involved and no actual or potential patient harm existed for the alleged event.The failure could not be determined as the product was not available for inspection.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.Corrective action/preventive action: a review of stryker¿s nc/capa database indicated there have been no ncs and capas associated with the product and failure mode reported in this event.H3 other text : device not returned.

Event Description

The green demayo boot has cracks in it.Concern for bioburden.Case type: tka.

• Brand Name: IMP DEMAYO KNEE POSITIONER-25" (SPARE)
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9481563
• MDR Text Key: 190195538
• Report Number: 3005985723-2019-00908
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 110580
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other