MAUDE Adverse Event Report: MAKO SURGICAL CORP. BASE BAR ASSM; STEREOTAXIC DEVICE, ROBOTICS

Model Number 210060

Device Problem Material Frayed (1262)

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

Event Date 01/30/2020

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

Cpd alerted me that the f bar used with the mako black leg holder was chipping away where the sled glide's and clamps down on.There was some splintering and now they are concerned with structural integrity, patient, and employee safety with the part and would like to have it replaced.Case type: no associated procedure.

Event Description

Cpd alerted me that the f bar used with the mako black leg holder was chipping away where the sled glide's and clamps down on.There was some splintering and now they are concerned with structural integrity, patient, and employee safety with the part and would like to have it replaced.Case type: no associated procedure.

Manufacturer Narrative

Reported event: cpd alerted me that the f bar used with the mako black leg holder was chipping away where the sled glide's and clamps down on.There was some splintering and now they are concerned with structural integrity, patient, and employee safety with the part and would like to have it replaced.Product evaluation and results: visual inspection confirms the base bar assembly has splintered along the bar.Product history review: review of the device history records indicate (b)(4) devices were manufactured and accepted into final stock on 05/17/2018.No non-conformances were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 210060, l/n 608112 shows no additional complaints related to the failure in this investigation.Conclusion: 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 was confirmed via visual 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 has been no nc or capa associated with the product and failure mode reported in this event.

• Brand Name: BASE BAR ASSM
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9758236
• MDR Text Key: 181355249
• Report Number: 3005985723-2020-00107
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486031855
• UDI-Public: 00848486031855
• Combination Product (y/n): N
• PMA/PMN Number: K143752
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/01/2020

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 Model Number: 210060
• Device Catalogue Number: 210060
• Device Lot Number: 608112
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/30/2020
• Initial Date FDA Received: 02/26/2020
• Supplement Dates Manufacturer Received: 03/20/2020
• Supplement Dates FDA Received: 04/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other