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

Catalog Number	210195
Medical Device Problem Codes	Device Damaged by Another Device (2915); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/07/2019
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
Gauges in retractor (found in cpd).Case type: no associated procedure.Can we please confirm how and when the retractors became damaged? during the procedure or in cpd? as per the mps: "i cannot say exactly when they were damaged since they were found in cpd, but my best guess is during the procedure due to the impact of the saw".
Additional Manufacturer Narrative
Reported event: customer reported gauges in retractor (found in cpd).Device evaluation and results: device evaluation was not performed and the patella retractor event was not confirmed.Device history review: review of the device history records indicate 99 devices were manufactured and inspected on 02-09-2017 with no reported discrepancies.Complaint history review: based on the device identification, the catsweb and trackwise complaint databases were reviewed from 2011 to present for similar reported events regarding the patella retractor.There have been no other events for the referenced part number that can be confirmed.Conclusions: no product inspection could be completed due to the product not being returned.Per (b)(4), preventive maintenance 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: as the event did not involve a manufacturing related product problem indicating a non-conformity, adverse trend, or unanticipated hazard, no corrective action is required at this time.
Event or Problem Description
Gauges in retractor (found in cpd).Case type: no associated procedure.Can we please confirm how and when the retractors became damaged? during the procedure or in cpd? as per the mps: "i cannot say exactly when they were damaged since they were found in cpd, but my best guess is during the procedure due to the impact of the saw".

• Brand Name: PATELLA RETRACTOR
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8633312
• Report Number: 3005985723-2019-00376
• Device Sequence Number: 1816163
• Product Code: OLO
• UDI-Device Identifier: 00848486031947
• UDI-Public: 00848486031947
• 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): 08/07/2019

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: 210195
• Device Lot Number: 31929
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/07/2019
• Supplement Date Received by Manufacturer: 07/29/2019
• Initial Report FDA Received Date: 05/22/2019
• Supplement Report FDA Received Date: 08/07/2019
• 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