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

Model Number	210070
Medical Device Problem Codes	Crack (1135); Material Frayed (1262); Sharp Edges (4013)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/13/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.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 or Problem 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.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.
Additional Manufacturer Narrative
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 11 devices were manufactured and 11 were accepted into final stock on 09/26/2018.No non-conformances were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 210070, lot number 609572, 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.

• Brand Name: BAR EXTENSION
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9577345
• Report Number: 3005985723-2020-00013
• Device Sequence Number: 19549799
• Product Code: OLO
• UDI-Device Identifier: 00848486031862
• UDI-Public: 00848486031862
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2020

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
• Operator of Device: Health Professional
• Device Model Number: 210070
• Device Catalogue Number: 210070
• Device Lot Number: 609572
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/13/2019
• Supplement Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 01/10/2020
• Supplement Report FDA Received Date: 03/18/2020
• 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