MAUDE Adverse Event Report: MAKO SURGICAL CORP. OFFSET CUP REAMER HANDLE; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number 212760

Device Problem Mechanical Problem (1384)

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

Event Date 11/06/2017

Event Type  malfunction  

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 Description

Offset cup reamer handle: screws missing; reamer handle won't insert into hand piece without resistance.Tha case.

Manufacturer Narrative

Follow-up #1 and final report submitted to update sections based on the results of investigation.Reported event: the event reported that an offset cup reamer handle was missing screws and would not insert into a handpiece.Device evaluation and results: visual inspection shows two missing screws from the shell housing of the device and wear at the proximal end of the shaft.See attached figures.Functional inspection shows that the device is unable to assemble to hip end effector due to the wear at the proximal end of the shaft.Device history review: review of device history records indicate 23 devices were dispositioned "use as is" per qt 17-03-0041 on 03/13/2017.The non conformance was unrelated to the failure in this complaint.Complaint history review: review of complaints for p/n 212760, l/n 3578682 within the trackwise show no other complaints related to the failure in this investigation.Conclusion: the failure was confirmed.Corrective action / preventive action: no action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.

Event Description

Offset cup reamer handle: screws missing; reamer handle won't insert into hand piece without resistance.Tha case.

• Brand Name: OFFSET CUP REAMER HANDLE
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 7147301
• MDR Text Key: 95917127
• Report Number: 3005985723-2017-00649
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• PMA/PMN Number: K170593
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 212760
• Device Lot Number: 3578682
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1