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

Catalog Number	210191
Medical Device Problem Codes	Mechanical Problem (1384); Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/09/2018
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
Retractor badly damaged due to saw hitting it.Per the mps, all the retractors were damaged and rigid.Case type: tka.
Additional Manufacturer Narrative
Follow-up #1 and final report submitted to update sections based on the results of investigation."reported event: per the mps, all the retractors were damaged.Product not returned.Refer to (b)(4).A review of the device history records indicate 150 devices were manufactured and accepted into final stock on (b)(6) 2017.No non-conformances were identified during inspection.A review of complaints in catsweb and trackwise related to p/n 210191, lot number 37831 shows no additional complaints related to the failure in this investigation.Conclusions: system ready for clinical use.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
Retractor badly damaged due to saw hitting it.Per the mps, all the retractors were damaged and rigid.Case type: tka.

• 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: 7756685
• Report Number: 3005985723-2018-00466
• Device Sequence Number: 16570385
• 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): 10/09/2018

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: 210191
• Device Lot Number: 37831
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/09/2018
• Supplement Date Received by Manufacturer: 09/30/2018
• Initial Report FDA Received Date: 08/07/2018
• Supplement Report FDA Received Date: 10/09/2018
• 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