MAUDE Adverse Event Report: MAKO SURGICAL CORP. BOOT ASSEMBLY; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number 210080

Device Problems Material Integrity Problem (2978); Material Split, Cut or Torn (4008)

Patient Problems No Known Impact Or Consequence To Patient (2692); Not Applicable (3189)

Event Date 09/12/2019

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

The proximal edge of the boot is fraying and spd is concerned that it may harbor microorganisms or harm the patient during a case.Case type: tka.

Manufacturer Narrative

The proximal edge of the boot is fraying and spd is concerned that it may harbor microorganisms or harm the patient during a case.Case type: tka.Product history review: review of the device history records indicate (b)(4) were manufactured and accepted into final stock on 12/02/2017.No non-conformances were identified during inspection.Complaint history review: a review of complaints related to p/n 210080, lot 201743092901 shows one additional complaint(s) related to the failure in this investigation.Product inspection: the reported device was confirmed to be a boot assembly.P/n 210080, lot/sn (b)(4).Inspection showed splintering/chips in the carbon fiber.See attached picture.Conclusion: the failure mode has been confirmed.The hazard/harm combination from this complaint has been previously identified.No additional investigation or specific actions are required.Per (b)(4), 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.No additional investigation or specific actions are required.

Event Description

The proximal edge of the boot is fraying and spd is concerned that it may harbor microorganisms or harm the patient during a case.Case type: tka.

• Brand Name: BOOT ASSEMBLY
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9079091
• MDR Text Key: 158897866
• Report Number: 3005985723-2019-00681
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486031879
• UDI-Public: 00848486031879
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/12/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 210080
• Device Lot Number: 201743092901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2019
• Initial Date Manufacturer Received: 09/12/2019
• Initial Date FDA Received: 09/17/2019
• Supplement Dates Manufacturer Received: 11/14/2019
• Supplement Dates FDA Received: 12/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization