MAUDE Adverse Event Report: MAKO SURGICAL CORP. EE DOUBLE ANGLE COLLET; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number	111748
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/07/2019
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
During the pka case earlier today, the small and large collet nut would not hold the anspach burr in place.This malfunction caused the anspach to move from the original registration position and subsequently not pass a registration check.In order to rectify this issue, we had to open the other pka tray that lives at (b)(6) and use the small and large collet nut from the set to complete the case.Case type: pka.
Additional Manufacturer Narrative
It was reported that the collet could not assemble the burr.Functional inspection was conducted on a known good anspach end effector assembly and the anspach motor remained secure when pulling the motor assembly or pushing on the burr.Review of device history records indicate 35 of 36 devices were manufactured and accepted into final stock on 03/19/2015.The non-conformance was not related to the alleged failure in this investigation and was not associated with this serialized device within the lot per npr 15-03-0035.A review of complaint records within the trackwise database based on p/n 111758, l/n 19010914 shows no complaint related to the alleged failure.Functional inspection was conducted on a known good anspach end effector assembly and the anspach motor remained secure when pulling the motor assembly or pushing on the burr.Reported failure mode could not be confirmed.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.
Event or Problem Description
During the pka case earlier today, the small and large collet nut would not hold the anspach burr in place.This malfunction caused the anspach to move from the original registration position and subsequently not pass a registration check.In order to rectify this issue, we had to open the other pka tray that lives at lsh and use the small and large collet nut from the set to complete the case.Case type: pka.

• Brand Name: EE DOUBLE ANGLE COLLET
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8351855
• Report Number: 3005985723-2019-00157
• Device Sequence Number: 2253382
• Product Code: OLO
• UDI-Device Identifier: 00848486002565
• UDI-Public: 00848486002565
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K112507
• 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): 06/28/2019

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: Health Professional
• Device Catalogue Number: 111748
• Device Lot Number: 19010914
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/07/2019
• Supplement Date Received by Manufacturer: 06/25/2019
• Initial Report FDA Received Date: 02/19/2019
• Supplement Report FDA Received Date: 06/28/2019
• 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