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

Catalog Number	207084
Medical Device Problem Codes	Mechanical Problem (1384); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/24/2018
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 spring on the reamer is broken.This was a tha procedure.
Additional Manufacturer Narrative
It was reported that the spring on the reamer is broken.This was a tha procedure.Product inspection could not be performed as the product was lost and not available for evaluation.Review of the device history records indicate 80 devices were manufactured under lot no 06030515 and accepted into final stock on 07/28/2015.No non-conformances were identified during inspection.A review of complaints in catsweb and trackwise related to p/n 207084, lot number 06030515 shows no additional complaints related to the failure in this investigation.The failure mode could not be confirmed because the part was not available for evaluation.If device and/or additional information become available, this investigation will be reopened.No action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.
Event or Problem Description
The spring on the reamer is broken.This was a tha procedure.

• Brand Name: STRAIGHT CUP REAMER HANDLE
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8077432
• Report Number: 3005985723-2018-00682
• Device Sequence Number: 1746097
• Product Code: OLO
• UDI-Device Identifier: 00848486022204
• UDI-Public: 00848486022204
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K121064
• 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): 01/14/2019

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: 207084
• Device Lot Number: 06030515¿
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/25/2018
• Supplement Date Received by Manufacturer: 01/10/2019
• Initial Report FDA Received Date: 11/16/2018
• Supplement Report FDA Received Date: 01/14/2019
• 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