MAUDE Adverse Event Report: MAKO SURGICAL CORP. CHECKPOINT, 3.5MM HEX X 15MM, STERILE; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number	116230
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/21/2018
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
Pelvic checkpoint break.
Additional Manufacturer Narrative
Reported event: it was reported that pelvic checkpoint break.Device evaluation and results: no device inspection could be completed as the product was not available for evaluation.Device history review: review of the product history records indicate 200 devices were manufactured under lot no w42823-1 and accepted into final stock on 09/08/2015.No non-conformance were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 116230 , lot number w42823-1 shows no additional complaints related to the failure in this investigation.Conclusions: ¿per d03391, preventive maintenance is where an action occurs that identifies device deterioration which may compromise function.Under pm conditions no patient was involved and no actual or potential patient harm existed for the alleged event.The alleged failure mode could not be confirmed as the product was not available for inspection.No additional investigation or specific actions are required.¿ 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.H3 other text : product was not available for evaluation.
Event or Problem Description
Pelvic checkpoint break.

• Brand Name: CHECKPOINT, 3.5MM HEX X 15MM, STERILE
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 7986220
• Report Number: 3005985723-2018-00609
• Device Sequence Number: 19180969
• Product Code: OLO
• UDI-Device Identifier: 00848486002978
• UDI-Public: 00848486002978
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• 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): 02/18/2019

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: 116230
• Device Lot Number: W42823-1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/21/2018
• Supplement Date Received by Manufacturer: 01/22/2019
• Initial Report FDA Received Date: 10/19/2018
• Supplement Report FDA Received Date: 02/18/2019
• 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