MAUDE Adverse Event Report: MAKO SURGICAL CORP. BENT HOHMANN RETRACTOR; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number	210191
Medical Device Problem Codes	Dent in Material (2526); Material Deformation (2976); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As part of the 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
Bent and gouged homan.Case type: no associated procedure.
Event or Problem Description
Bent and gouged homan.Case type: no associated procedure.
Additional Manufacturer Narrative
Reported event: bent and gouged homan.Case type: no associated procedure.Product evaluation and results: visual inspection: confirms the mako retractor is bent and gouged.Product history review: review of the product history records indicate (b)(4) devices were manufactured under lot no 44155, and accepted into final stock on 11/27/2018.No non-conformances were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 210191, lot number 43245, shows 00 additional complaints related to the failure in this investigation.Conclusions: the event was confirmed.Per (b)(4), 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.No additional investigation or specific actions are required.Corrective action/preventive action: a review of stryker¿s nc/capa database indicated there have been no nc and capa associated with the product and failure mode reported in this event.

• Brand Name: BENT HOHMANN RETRACTOR
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9327694
• Report Number: 3005985723-2019-00807
• Device Sequence Number: 2272033
• Product Code: OLO
• UDI-Device Identifier: 00848486031909
• UDI-Public: 00848486031909
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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): 12/30/2019

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: 210191
• Device Lot Number: 44155
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/25/2019
• Supplement Date Received by Manufacturer: 12/05/2019
• Initial Report FDA Received Date: 11/15/2019
• Supplement Report FDA Received Date: 12/30/2019
• 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