MAUDE Adverse Event Report: MAKO SURGICAL CORP. PELVIC ARRAY ADAPTOR ASSY; STEREOTAXIC DEVICE, ROBOTICS

Model Number 112240

Device Problems Mechanical Problem (1384); Misassembled (1398); Use of Device Problem (1670); Misassembly by Users (3133)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/06/2019

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

Pelvic array and pelvic array clamp got cross threaded and need to be replaced.Case type: tha.

Manufacturer Narrative

Reported event: pelvic array and pelvic array clamp got cross threaded and need to be replaced.Product evaluation and results: visual inspection.The product was not evaluated as the product was unavailable for inspection capa 2127499 has been raised for the same.Product history review: review of the device history records indicate 31 devices were manufactured and accepted into final stock on 10/31/2011.No non-conformances were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 112240, lot number 19010811 shows no additional complaints related to the failure in this investigation.Conclusions: 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 nc and capa associated with the product and failure mode reported in this event.H3 other text : device not returned.

Event Description

Pelvic array and pelvic array clamp got cross threaded and need to be replaced.Case type: tha.

• Brand Name: PELVIC ARRAY ADAPTOR ASSY
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9373759
• MDR Text Key: 175413995
• Report Number: 3005985723-2019-00841
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486002930
• UDI-Public: 00848486002930
• Combination Product (y/n): N
• PMA/PMN Number: K121064
• 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: 11/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 112240
• Device Catalogue Number: 112240
• Device Lot Number: 19010811
• 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): Hospitalization
• Patient Age: 79 YR