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

Catalog Number	210070
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As part of 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
The bar extension assembly in the new stryker leg holder had exposed carbon fibers when removed from package.Case type: no associated procedure.
Additional Manufacturer Narrative
Follow-up #1 and final report submitted.Reported issue: it was reported that the base bar extension was damaged.Product history review: review of the device history records indicate 75 devices were manufactured and accepted into final stock on 07/06/2018.Complaint history review: a review of complaints related to p/n 210070, lot 608499 shows no additional complaint(s) related to the failure in this investigation.Inspection: inspection showed no damage to the part.Conclusion: the failure mode was not confirmed.The hazard/harm combination from this complaint has been previously identified.No additional investigation or specific actions are required.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.
Event or Problem Description
The bar extension assembly in the new stryker leg holder had exposed carbon fibers when removed from package.Case type: no associated procedure.

• 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: 8431797
• Report Number: 3005985723-2019-00244
• Device Sequence Number: 1633447
• Product Code: OLO
• UDI-Device Identifier: 00848486031862
• UDI-Public: 00848486031862
• Combination Product (Y/N): N
• 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): 05/28/2019

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: Other
• Device Catalogue Number: 210070
• Device Lot Number: 608499
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/28/2019
• Supplement Date Received by Manufacturer: 05/16/2019
• Initial Report FDA Received Date: 03/19/2019
• Supplement Report FDA Received Date: 05/28/2019
• 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: Hospitalization