MAUDE Adverse Event Report: MAKO SURGICAL CORP. HANDPIECE MICS; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 209063

Device Problem Failure to Calibrate (2440)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/09/2020

Event Type  malfunction  

Manufacturer Narrative

Stryker has initiated a voluntary, serial number specific recall for the mako integrated cutting system (mics) within scope of pfa.An updated communication will be forwarded upon completion of the internal investigation on this issue.Recall number will be provided once available.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 Description

Angled blade will not pass on robot.If you physically move the blade to one end of the "sweep" it says it's off by 5 or 6mm.If you move it to the other end it passes.Tried multiple attachments and mics, and it still did this.Even got attachments from another facility to test.Case type / application: tka.

Manufacturer Narrative

Reported issue.Angled blade will not pass on robot.If you physically move the blade to one end of the "sweep" it says it's off by 5 or 6mm.If you move it to the other end it passes.Tried multiple attachments and mics and it still did this.Even got attachments from another facility to test.Case type / application: tka.Product inspection.Product was not inspected as the product was not returned for evaluation device history review.Review of the device history records indicate (b)(4) devices were manufactured under lot id 42070420, and (b)(4) were accepted into final stock on 18 may 2020.No non-conformances were identified during inspection.Complaint history review.A review of complaints in catsweb and trackwise related to p/n 209063, lot number 42070420 shows no additional complaints related to the failure in this investigation.Conclusion: preventive maintenance is where an action occurs that 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.The alleged failure mode could not be confirmed as the product was not available for inspection.No additional investigation or specific actions are required.Serial specific voluntary recall was initiated for the mako integrated cutting system (mics) within scope of a capa.The initial root cause analysis determined that the process for characterizing mics handpieces for specific serial numbers deviated from its qualified state at the time of validation.Device not returned.

Event Description

Angled blade will not pass on robot.If you physically move the blade to one end of the "sweep" it says it's off by 5 or 6mm.If you move it to the other end it passes.Tried multiple attachments and mics and it still did this.Even got attachments from another facility to test.Case type / application: tka.

Manufacturer Narrative

Reported issue angled blade will not pass on robot.If you physically move the blade to one end of the "sweep" it says it's off by 5 or 6mm.If you move it to the other end it passes.Tried multiple attachments and mics and it still did this.Even got attachments from another facility to test.Case type / application: tka product inspection the failure is confirmed as it is under the scope of nc: mics characterization process deviated from the qualified state.Also the serial number (b)(6) lies in the urgent medical device recall list.Although the product was not received for evaluation.Device history review of the device history records indicate 25 devices were manufactured under lot id 42070420, and 25 were accepted into final stock on 18 may 2020.No non-conformances were identified during inspection.Complaint history review a review of complaints in catsweb and trackwise related to p/n 209063, lot number 42070420 shows 5 additional complaints related to the failure in this investigation.Conclusion the failure is confirmed as it is under the scope of nc: mics characterization process deviated from the qualified state.Also the serial number (b)(6) lies in the urgent medical device recall list.Although the product was not received for evaluation.No additional investigation or specific actions are required.

Event Description

Angled blade will not pass on robot.If you physically move the blade to one end of the "sweep" it says it's off by 5 or 6mm.If you move it to the other end it passes.Tried multiple attachments and mics and it still did this.Even got attachments from another facility to test case type / application: tka.

• Brand Name: HANDPIECE MICS
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 10754498
• MDR Text Key: 213655041
• Report Number: 3005985723-2020-00322
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2020
• 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: 42070420
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0472-2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other