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

Model Number 111160

Device Problem Misassembly by Users (3133)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/05/2019

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

Silver end of square driver came loose from the blue handle while taking apart arrays/array clamps.Case type: pka (anspach).Surgical delay: > 30 minutes.

Manufacturer Narrative

Reported event: -customer reported that the silver end of square driver came loose from the blue handle while taking apart arrays/array clamps.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 379 devices were manufactured and inspected on 07-02-2018 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 50 other events for the referenced lot number.Prs # 1914925, 1919787, 1935822, 1943690, 1947954, 1953514, 1967031, 1970724, 1987510, 1978669, 1995528, 2001610, 2017816, 2018871, 2019846, 2022521, 2028928, 2030818, 2031968, 2036455, 2045046, 2045740, 2051183, 2073709, 2082053, 2103869, 2114279, 2114688, 2117018, 2122244, 2125456, 2127852, 2139397, 2149504, 215096, 2154940, 21666790, 2188146, 2188148, 2192078, 2204673, 2208809, 2209518, 2210264 , 2210272, 2211307, 2213526, 2221304, 2221688 and 2228967 - were found to be from the same lot as the part in this complaint.The parts from these prs displayed the same failure.Conclusions: the square screwdriver showed the masterbond that holds the shaft and handle cracked.Corrective action/preventive action: a review of stryker¿s nc/capa database indicated that capa 1694870 was initiated for this part number.

Event Description

Silver end of square driver came loose from the blue handle while taking apart arrays/array clamps.Case type: pka (anspach).Surgical delay: > 30 minutes.

• Brand Name: SQUARE SCREWDRIVER
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9378968
• MDR Text Key: 189676180
• Report Number: 3005985723-2019-00856
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486002763
• UDI-Public: 00848486002763
• Combination Product (y/n): N
• PMA/PMN Number: K112507
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/03/2020

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
• Device Operator: Health Professional
• Device Model Number: 111160
• Device Catalogue Number: 111160
• Device Lot Number: 06110518
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/05/2019
• Initial Date FDA Received: 11/26/2019
• Supplement Dates Manufacturer Received: 01/13/2020
• Supplement Dates FDA Received: 02/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization