MAUDE Adverse Event Report: MAKO SURGICAL CORP. 2.7 DEGREE STRAIGHT SAGITAL SAW; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	212186
Medical Device Problem Code	Residue After Decontamination (2325)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Straight saw attachment has become greasy black after sterilization process and washing process, as if a seal has been broken.Oil and wash water leaked from the inside.
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
Straight saw attachment has become greasy black after sterilization process and washing process, as if a seal has been broken.Oil and wash water leaked from the inside.
Additional Manufacturer Narrative
Reported event.An event regarding foreign matter involving a mako saw attachment was reported.The event was confirmed.Method & results.-product evaluation and results: visual inspection has confirmed the reported event: the device arrived sealed in a bag with a decontamination log.Upon inspection, oil is present at the inlet gears of the device.Inspector also noticed that the inlet gears on the device were unable to turn, and that the inlet ring at the base of the saw attachment is no longer flush to the device.-clinician review: no medical records were received for review with a clinical consultant.-product history review: a product history review is not required, as no manufacturing specific issue has been alleged.At stryker joint replacement all devices/product are manufactured through validated equipment and inspected by trained representatives through stryker¿s quality management system.-complaint history review: a complaint history review and trend detection is not required as this is a pm.Monitoring will be continued under the current quarterly trend review.Conclusions: no patient was involved and no actual or potential patient harm existed for the alleged event.The alleged failure mode was not confirmed because 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.
Additional Manufacturer Narrative
Reported event.An event regarding foreign matter involving a mako saw attachment was reported.The event was confirmed.Method & results.-product evaluation and results: visual inspection has confirmed the reported event: the device arrived sealed in a bag with a decontamination log.Upon inspection, oil is present at the inlet gears of the device.Inspector also noticed that the inlet gears on the device were unable to turn, and that the inlet ring at the base of the saw attachment is no longer flush to the device.-clinician review: no medical records were received for review with a clinical consultant.-product history review: a product history review is not required, as no manufacturing specific issue has been alleged.At stryker joint replacement all devices/product are manufactured through validated equipment and inspected by trained representatives through stryker¿s quality management system.-complaint history review: a complaint history review and trend detection is not required as this is a pm.Monitoring will be continued under the current quarterly trend review.Conclusions: no patient was involved and no actual or potential patient harm existed for the alleged event.The alleged failure mode was not confirmed because 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.
Event or Problem Description
Straight saw attachment has become greasy black after sterilization process and washing process, as if a seal has been broken.Oil and wash water leaked from the inside.

• Brand Name: 2.7 DEGREE STRAIGHT SAGITAL SAW
• Common Device Name: 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: 16499227
• Report Number: 3005985723-2023-00047
• Device Sequence Number: 6536265
• Product Code: OLO
• UDI-Device Identifier: 00848486032111
• UDI-Public: 00848486032111
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K143752
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/07/2023

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
• Operator of Device: Health Professional
• Device Model Number: 212186
• Device Catalogue Number: 212186
• Device Lot Number: 35030419 / 3506432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/10/2023
• Supplement Date Received by Manufacturer: 06/06/2023; 06/30/2023
• Initial Report FDA Received Date: 03/07/2023
• Supplement Report FDA Received Date: 06/29/2023; 07/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown