MAUDE Adverse Event Report: MAKO SURGICAL CORP. SQUARE SCREWDRIVER; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number	111160
Medical Device Problem Codes	Crack (1135); Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/17/2019
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
The handle on the mics/array wrench became loose upon disassembling the arrays.Case type: tka.Surgical delay: yes > 30 minutes.
Event or Problem Description
The handle on the mics/array wrench became loose upon disassembling the arrays.Case type: tka.Surgical delay : yes > 30 minutes.
Additional Manufacturer Narrative
Customer reported that the handle on the mics/array wrench became loose upon disassembling the arrays.Device evaluation and results: device evaluation was performed and the square screwdriver event was confirmed.Device history review: review of the device history records indicate 130 devices were received and accepted into final stock on 08-21-2018 with no reported discrepancies.Complaint history review: based on the device identification, the catsweb and trackwise complaint databases were reviewed from 2011 to present for similar reported events regarding the square screwdriver.There have been 16 other events for the referenced lot number.The parts from these prs displayed the same failure.Conclusions: the square screwdriver showed the masterbond that holds the shaft and handle cracked.

• Brand Name: SQUARE SCREWDRIVER
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9258402
• Report Number: 3005985723-2019-00763
• Device Sequence Number: 13966743
• Product Code: OLO
• UDI-Device Identifier: 00848486002763
• UDI-Public: 00848486002763
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 01/14/2020

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 Catalogue Number: 111160
• Device Lot Number: 06050818
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Initial Date Received by Manufacturer: 10/17/2019
• Supplement Date Received by Manufacturer: 12/16/2019
• Initial Report FDA Received Date: 10/30/2019
• Supplement Report FDA Received Date: 01/14/2020
• 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: Hospitalization