MAUDE Adverse Event Report: MAKO SURGICAL CORP. BONE PIN, 3.2MM X 80MM, STERILE 2 PACK; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number	143080
Medical Device Problem Codes	Material Integrity Problem (2978); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/30/2018
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
Doctor removed the reference tip from the tibia and the tip was missing in the bone.
Event or Problem Description
Doctor removed the reference tip from the tibia and the tip was missing in the bone.
Additional Manufacturer Narrative
Reported event: doctor removed the reference tip from the tibia and the tip was missing in the bone.Product evaluation and results: the product was unavailable for inspection as the product was not returned.Product history review: review of the product history records indicate 2438 devices were manufactured under lot no: w47865 and accepted into final stock on 01/24/2017.Complaint history review: a review of complaints in catsweb and trackwise related to p/n: 143080, l/n: w47865 shows 0 additional complaints related to the failure in this investigation.Conclusions: 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.Corrective action/preventive action: a review of stryker¿s nc/capa database indicated there have been an nc: 1470754 and capa: 1480798 associated with the product and failure mode reported in this event.

• Brand Name: BONE PIN, 3.2MM X 80MM, STERILE 2 PACK
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 7586295
• Report Number: 3005985723-2018-00355
• Device Sequence Number: 13782475
• Product Code: OLO
• UDI-Device Identifier: 00848486018122
• UDI-Public: 00848486018122
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K112507
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2018

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: 143080
• Device Lot Number: W47865-1
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/07/2018
• Supplement Date Received by Manufacturer: 09/19/2018
• Initial Report FDA Received Date: 06/11/2018
• Supplement Report FDA Received Date: 09/25/2018
• 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