MAUDE Adverse Event Report: MAKO SURGICAL CORP. HIGH SPEED ROTARY ATTACHMENT; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number	204990
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	10/01/2018
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
Scrub reported plastic piece stuck on burr after case.Unsure if piece came from burr guard or rotary attachment.Case type: pka.
Additional Manufacturer Narrative
Follow-up #1 and final report submitted to update mfr name, city & state,mfr site, date received by mfr, type of report, follow up type, device evaluated by mfr, evaluation codes, additional narrative and corrected data based on the results of investigation.Reported issue: it was reported that there was a plastic piece on burr.Product history review: review of the device history records indicate (b)(4) devices were manufactured and accepted into final stock on 4/12/2018.No non-conformances were identified during inspection.Complaint history review: a review of complaints related to p/n 204990, lot 40m059720 shows no additional complaint(s) related to the failure in this investigation.Visual inspection: visual inspection showed no issue with product.Issue is limited to burr guard (pr 1906924).Material analysis: material analysis not needed as no foreign material suspected.Conclusion: no issue with product.Issue is limited to burr guard (pr 1906924).Corrective action/preventive action: a review of stryker¿s nc/capa database indicated there has been no nc or capa associated with the product and failure mode reported in this event.
Event or Problem Description
Scrub reported plastic piece stuck on burr after case.Unsure if piece came from burr guard or rotary attachment.Case type: pka.
Additional Manufacturer Narrative
Follow-up #2 and final report submitted.
Event or Problem Description
Scrub reported plastic piece stuck on burr after case.Unsure if piece came from burr guard or rotary attachment.Case type: (b)(4).

• Brand Name: HIGH SPEED ROTARY ATTACHMENT
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8025718
• Report Number: 3005985723-2018-00638
• Device Sequence Number: 1369306
• Product Code: OLO
• UDI-Device Identifier: 00848486021849
• UDI-Public: 00848486021849
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K142530
• 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,Followup
• Report Date (Section B): 05/30/2019

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: 204990
• Device Lot Number: 40M059720
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/01/2018
• Supplement Date Received by Manufacturer: 12/17/2018; 05/28/2019
• Initial Report FDA Received Date: 10/31/2018
• Supplement Report FDA Received Date: 12/26/2018; 05/30/2019
• 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