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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. BASE BAR ASSM; STEREOTAXIC DEVICE, ROBOTICS
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MAKO SURGICAL CORP. BASE BAR ASSM; STEREOTAXIC DEVICE, ROBOTICS Back to Search Results
Model Number 210060
Device Problems Crack (1135); Material Frayed (1262); Sharp Edges (4013)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/13/2019
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
Stryker mako leg holders.Numerous pieces have exposed fibers, two pieces have stress fractures at the point where the metal fitting is inserted.Report of "someone getting stuck" by an exposed fiber.Comment was made by spd manager barbara williams, during a conversation.Case type: tka.Patient was under anesthesia.Update : how many surgeries were involved with the reported issue? approximately 300 procedures to get to this point.All the reported devices that are included in this complaint were for one or many surgeries? many ¿ spd called us concerned about exposed fibers and cracks.Have you reported each incident separately that has the issues you have mentioned in this complaint? (if no, please submit a complaint for each issue.) no ¿ multiple leg holders are exhibiting wear.The items listed in the per either have exposed fibers or cracks.Please confirm if there was a patient that was ¿stuck¿ by the exposed carbon fiber? not a patient ¿ a staff member.
 
Event Description
Stryker mako leg holders.Numerous pieces have exposed fibers, two pieces have stress fractures at the point where the metal fitting is inserted.Report of "someone getting stuck" by an exposed fiber.Comment was made by spd manager barbara williams, during a conversation.Case type: tka.Patient was under anesthesia.Update : how many surgeries were involved with the reported issue? approximately 300 procedures to get to this point.All the reported devices that are included in this complaint were for one or many surgeries? many ¿ spd called us concerned about exposed fibers and cracks.Have you reported each incident separately that has the issues you have mentioned in this complaint? (if no, please submit a complaint for each issue.) no ¿ multiple leg holders are exhibiting wear.The items listed in the per either have exposed fibers or cracks.Please confirm if there was a patient that was ¿stuck¿ by the exposed carbon fiber? not a patient.A staff member.
 
Manufacturer Narrative
Corrected: type of reportable event.Reported event: stryker mako leg holders.Numerous pieces have exposed fibers, two pieces have stress fractures at the point where the metal fitting is inserted.Report of "someone getting stuck" by an exposed fiber.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: review of the device history records indicate (b)(4) were manufactured and 32 were accepted into final stock on 01/31/2019.No non-conformances were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 210060, lot number 615078, shows no additional complaints related to the failure in this investigation.Conclusion: 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 has been no nc or capa associated with the product and failure mode reported in this event.H3 other text : device not returned.
 
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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 Key9577462
MDR Text Key175447479
Report Number3005985723-2020-00016
Device Sequence Number1
Product Code OLO
UDI-Device Identifier00848486031855
UDI-Public00848486031855
Combination Product (y/n)N
PMA/PMN Number
K143752
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 03/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number210060
Device Catalogue Number210060
Device Lot Number615078
Was Device Available for Evaluation? Yes
Date Manufacturer Received02/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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