MAUDE Adverse Event Report: MAKO SURGICAL CORP. TIBIAL ARRAY; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number	112280
Medical Device Problem Codes	Output Problem (3005); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/18/2019
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
During a mako tka the surgeon had difficult maintaining a registration on the tibia and femur.On inspection the array itself was wobbly at the centre attachment.Surgical delay of approximately 1 hour.
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 "during a mako tka the surgeon had difficult maintaining a registration on the tibia and femur.On inspection the array itself was wobbly at the centre attachment." the event was not confirmed.Method & results: -device evaluation and results: not performed as no items were returned.-product history review: review of the device history records indicates 100 device(s) were manufactured and accepted into final stock on 14may2018 with no reported discrepancies.-complaint history review: a review of complaints in catsweb and trackwise related to p/n 112280, lot 19160218 shows 00 additional complaint(s) related to the failure in this investigation.Conclusion: the exact cause of the event could not be determined because the product was not received.No further investigation for this event is possible at this time as no devices and / or insufficient information was received by stryker orthopaedics.If devices and / or additional information become available, this investigation will be reopened.Product surveillance will continue to monitor for trends corrective action/preventive action: no action is required at this time as there is no confirmed failure mode.H3 other text : product was not available for evaluation.
Event or Problem Description
During a mako tka the surgeon had difficult maintaining a registration on the tibia and femur.On inspection the array itself was wobbly at the centre attachment.Surgical delay of approximately 1 hour.

• Brand Name: TIBIAL ARRAY
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8858171
• Report Number: 3005985723-2019-00546
• Device Sequence Number: 11380224
• Product Code: OLO
• UDI-Device Identifier: 00848486015923
• UDI-Public: 00848486015923
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K142530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2019

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: 112280
• Device Lot Number: 19160218
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/18/2019
• Supplement Date Received by Manufacturer: 09/23/2019
• Initial Report FDA Received Date: 08/02/2019
• Supplement Report FDA Received Date: 09/25/2019
• 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