MAUDE Adverse Event Report: MAKO SURGICAL CORP. J5 BUMPSTOP RAIL; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 209704

Device Problems Positioning Failure (1158); Mechanical Jam (2983)

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

Event Date 11/28/2023

Event Type  malfunction  

Event Description

Case number: (b)(4): mps says that she is having multiple issues with j5.She is having issues moving j5 throughout the full range of motion in the angle discrepancy check and the arm is not aligning to cuts properly.Tka work performed: having issues moving j5 throughout the full range of motion in the angle discrepancy check and the arm is not aligning to cuts properly.J5 bump stop created friction during rotation.J6 needed adjustment.J2 bump stop needed recalibration.Ndi camera needed adjustment.Replaced j5 bump stop and rail.Propagated & tensioned j6 to specification.

Manufacturer Narrative

The following devices were also listed in this report: j5 bumpstop carriage; cat # 209705; lot # unknown.It cannot be determined which, if any of these devices may have caused or contributed to the event.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.H3 other text : not available.

Manufacturer Narrative

An event regarding mechanical failure involving a mako robotic arm was reported.The event was confirmed.Method & results: -product evaluation and results: the field service engineer reported: problem reproduced: yes.Troubleshooting notes: none.Work performed: reported problem ¿ mps says that she is having multiple issues with j5.She is having issues moving j5 throughout the full range of motion in the angle discrepency check and the arm is not aligning to cuts properly.Observation ¿ j5 bump stop created friction during rotation.J6 needed adjustment.J2 bump stop needed recalibration.Ndi camera needed adjustment.Action taken ¿ replaced j5 bump stop and rail.Propagated & tensioned j6 to specification.Recalibrated j2 bump stops to specification.Tighten manfrotto mount to support ndi camera.System ready for clinical use.Work order disposition: system investigation completed successfully as per service manual.All system checks and tests passed, system is ready for use.-clinician review: no medical records were received for review with a clinical consultant.-product history review: could not be performed as the lot details were not provided.-complaint history review: could not be performed as the lot details were not provided.Conclusions: the alleged failure mode was confirmed.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.

Event Description

Mps says that she is having multiple issues with j5.She is having issues moving j5 throughout the full range of motion in the angle discrepancy check and the arm is not aligning to cuts properly.Tka.Work performed: having issues moving j5 throughout the full range of motion in the angle discrepancy check and the arm is not aligning to cuts properly.J5 bump stop created friction during rotation.J6 needed adjustment.J2 bump stop needed recalibration.Ndi camera needed adjustment.Replaced j5 bump stop and rail.Propagated & tensioned j6 to specification.

• Brand Name: J5 BUMPSTOP RAIL
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 3365 enterprise ave; weston FL 33331
• Manufacturer (Section G): MAKO SURGICAL CORP.; 3365 enterprise ave; weston FL 33331
• Manufacturer Contact: kelsey williams ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18326462
• MDR Text Key: 330497831
• Report Number: 3005985723-2023-00183
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/06/2024

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: 209704
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/28/2023
• Initial Date FDA Received: 12/14/2023
• Supplement Dates Manufacturer Received: 01/11/2024
• Supplement Dates FDA Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other