MAUDE Adverse Event Report: MAKO SURGICAL CORP. PELVIC ARRAY ADAPTOR ASSY; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number	112240
Medical Device Problem Codes	Mechanical Problem (1384); Misassembly by Users (3133)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/18/2019
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
After surgery was completed, taking apart the femoral array the scrub tech and i noticed the array adapter and femoral array were cross-threaded.Case type: tka.Patient was under anesthesia.
Event or Problem Description
After surgery was completed, taking apart the femoral array the scrub tech and i noticed the array adapter and femoral array were cross-threaded.Case type: tka patient was under anesthesia.
Additional Manufacturer Narrative
Follow-up #1 and final report submitted to update sections d.3, g.1, g.4, g.7, h.2, h.3, h.6, h.10 and h.11 based on the results of investigation.Reported event: it was reported that "after surgery was completed, taking apart the femoral array the scrub tech and i noticed the array adapter and femoral array were cross-threaded.Case type: tka patient was under anesthesia." the event was confirmed.Method & results: -device evaluation and results: visual inspection: the adaptor showed signs of damage.See attached images.Functional inspection: the device is non-functional.Product history review: review of the device history records indicates 200 device(s) were manufactured and accepted into final stock on 09oct2017 with no reported discrepancies.-complaint history review: a review of complaints in catsweb and trackwise related to p/n 112240, lot 19030517 shows 00 additional complaint(s) related to the failure in this investigation.Conclusion: the investigation concluded that alleged failure mode was caused by damage.Product surveillance will continue to monitor for trends.Corrective action/preventive action: no action is required at this time as there is no indication or evidence available at this time to suggest that there was a product non- conformity or unanticipated hazard.Should additional information become available the investigation will be reopened and re- evaluated.

• Brand Name: PELVIC ARRAY ADAPTOR ASSY
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9100864
• Report Number: 3005985723-2019-00687
• Device Sequence Number: 2622540
• Product Code: OLO
• UDI-Device Identifier: 00848486002930
• UDI-Public: 00848486002930
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K121064
• 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): 11/28/2019

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: 112240
• Device Lot Number: 19030517
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/18/2019
• Supplement Date Received by Manufacturer: 11/07/2019
• Initial Report FDA Received Date: 09/20/2019
• Supplement Report FDA Received Date: 11/28/2019
• 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
• Patient Age: 81 YR
• Patient Weight: 70