MAUDE Adverse Event Report: MAKO SURGICAL CORP. HANDPIECE MICS; STEREOTAXIC DEVICE, ROBOTICS

Model Number 209063

Device Problems Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/17/2019

Event Type  malfunction  

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 Description

Small screw fell out of bottom of mics handpiece during bone prep.Screw is non-sterile and fell onto surgical field.Mako tka.Update: were any debris/components left inside of the patient? no.Were any components of the device missing or disassembled when the issue occurred? yes ¿ screw from handpiece fell out during bone cutting.All components (to my knowledge) were recovered and accounted for after the case.Were there any components that become fully detached during surgery? yes ¿ screw from handpiece.¿medical intervention¿ was selected as ¿yes¿.Was that in error, if not, what steps were taken as part of the medical intervention? "a betadine washout was conducted prior to closing the incision which is not part of dr (b)(4) standard practice.

Manufacturer Narrative

Reported issue: small screw fell out of bottom of mics handpiece during bone prep.Screw is non-sterile and fell onto surgical field.Mako tka.Update: were any debris/components left inside of the patient? no.2.Were any components of the device missing or disassembled when the issue occurred? yes ¿ screw from handpiece fell out during bone cutting.All components (to my knowledge) were recovered and accounted for after the case.3.Were there any components that become fully detached during surgery? yes ¿ screw from handpiece.¿medical intervention¿ was selected as ¿yes¿.Was that in error, if not, what steps were taken as part of the medical intervention? "a betadine washout was conducted prior to closing the incision which is not part of dr (b)(6) standard practice.Product inspection: product was not inspected as the product was not returned for evaluation.Device history review: a review of complaints in catsweb and trackwise related to p/n 209063, lot number 42031016 shows 01 additional complaint related to the failure in this investigation.Pr 1736427.Complaint history review: device history records indicate 25 devices were manufactured under lot 42031016 and 25 devices were rejected on 01/31/2017.A review of qt17-01-0114 revealed that the (b)(4) devices were rejected for wrong revision on c o c and 1 device for missing characterization data.All this units were accepted when document was received.Conclusion: the alleged failure mode could not be confirmed as the product was not available for inspection.No additional investigation or specific actions are required.Nc/capa review: 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.

Event Description

Small screw fell out of bottom of mics handpiece during bone prep.Screw is non-sterile and fell onto surgical field.Mako tka.Update: were any debris/components left inside of the patient? no.2.Were any components of the device missing or disassembled when the issue occurred? yes ¿ screw from handpiece fell out during bone cutting.All components (to my knowledge) were recovered and accounted for after the case.3.Were there any components that become fully detached during surgery? yes ¿ screw from handpiece.¿medical intervention¿ was selected as ¿yes¿.Was that in error, if not, what steps were taken as part of the medical intervention? "a betadine washout was conducted prior to closing the incision which is not part of dr (b)(6) standard practice.

• Brand Name: HANDPIECE MICS
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9258434
• MDR Text Key: 180550698
• Report Number: 3005985723-2019-00780
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486030193
• UDI-Public: 00848486030193
• Combination Product (y/n): N
• PMA/PMN Number: K142530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 209063
• Device Catalogue Number: 209063
• Device Lot Number: 4201263
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 60 YR