MAUDE Adverse Event Report: MAKO SURGICAL CORP. ARRAY- RIO BASE; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number	112227
Medical Device Problem Codes	Break (1069); Non Reproducible Results (4029)
Health Effect - Clinical Codes	Tissue Damage (2104); No Known Impact Or Consequence To Patient (2692)
Date of Event	04/04/2019
Type of Reportable Event	Serious Injury
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
It was reported by the distributor that the base array was installed by the nurse on the robot.During installation, a noise was heard (one of the pins on the base array may have been broken at that time), but at that point the nurse confirmed that it was stable.Intraoperatively, it was discovered by the surgeon that the base array was moving, which caused inaccuracy in the bone preparation, resulting in over removal of the femur bone which he had to eventually convert to a total knee replacement due to that.Post operatively, it was discovered that a pin from the base array was broken which caused the instability, leading to inaccurate bone removal.
Event or Problem Description
It was reported by the distributor that the base array was installed by the nurse on the robot.During installation, a noise was heard (one of the pins on the base array may have been broken at that time), but at that point the nurse confirmed that it was stable.Intraoperatively, it was discovered by the surgeon that the base array was moving, which caused inaccuracy in the bone preparation, resulting in over removal of the femur bone which he had to eventually convert to a total knee replacement due to that.Post operatively, it was discovered that a pin from the base array was broken which caused the instability, leading to inaccurate bone removal.Update: 1.Was case was converted from a pka to a tka based on the event?.Yes.Update: right side.Surgical procedure completed manually.
Additional Manufacturer Narrative
Reported event: it was reported by the distributor that the base array was installed by the nurse on the robot.During installation, a noise was heard (one of the pins on the base array may have been broken at that time), but at that point the nurse confirmed that it was stable.Intraoperatively, it was discovered by the surgeon that the base array was moving, which caused inaccuracy in the bone preparation, resulting in over removal of the femur bone which he had to eventually convert to a total knee replacement due to that.Post operatively, it was discovered that a pin from the base array was broken which caused the instability, leading to inaccurate bone removal.Product evaluation and results: visual inspection: visual inspection confirmed broken locking pin.See attachment 1 for image of the instrument.Dimensional inspection: dimensional inspection was not completed since visual inspection and functional inspection confirmed broken locking pin.Functional inspection: functional inspection confirmed broken locking pin would not allow for secure placement of base array during insertion and twisting to engage.Product history review: 1.Review of the device history records indicate 78 devices were manufactured and accepted into final stock on 02-06-2017 with no reported discrepancies.2.Review of the device history records indicate 22 devices were manufactured and accepted into final stock on 02-25-2017 with no reported discrepancies.Complaint history review: a review of complaints in catsweb and trackwise related to p/n (b)(4), lot number 19071016 shows no additional complaints related to the failure in this investigation.Conclusions: per d03391, the failure could not be determined as the product was not available for inspection.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.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.H3 other text : product was not available for evaluation.

• Brand Name: ARRAY- RIO BASE
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8573855
• Report Number: 3005985723-2019-00332
• Device Sequence Number: 19378707
• Product Code: OLO
• UDI-Device Identifier: 00848486017446
• UDI-Public: 00848486017446
• Combination Product (Y/N): N
• Initial Reporter Country: SG
• PMA/510(K) Number: K142530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 112227
• Device Lot Number: 19071016
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/17/2019
• Supplement Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 05/02/2019
• Supplement Report FDA Received Date: 08/30/2019
• 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: Other