MAUDE Adverse Event Report: MAKO SURGICAL CORP. HIGH SPEED ROTARY ATTACHMENT; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	204990
Medical Device Problem Code	Residue After Decontamination (2325)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2023
Type of Reportable Event	Malfunction
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
After multiple washes, sterilization and detailed cleaning, there is present oil or fluids coming out of saw attachment.Also black residue left on lip of saw attachment that is coming off on gloves but is not coming off with sterilization.Discovered during pre-op, no patient under anesthesia, no delay.Case type / application: pka 3.0.
Additional Manufacturer Narrative
An event regarding foreign matter involving a mako rotary attachment was reported.The event was not confirmed.Method & results -product evaluation and results: visual inspection does not confirm the alleged presence of foreign matter -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: there was no patient was involved and no actual or potential patient harm existed for the alleged event.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 or Problem Description
After multiple washes, sterilization and detailed cleaning, there is present oil or fluids coming out of saw attachment.Also black residue left on lip of saw attachment that is coming off on gloves but is not coming off with sterilization.Discovered during pre-op, no patient under anesthesia, no delay.Case type / application: pka 3.0.

• Brand Name: HIGH SPEED ROTARY ATTACHMENT
• 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: susan kinney ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16342247
• Report Number: 3005985723-2023-00027
• Device Sequence Number: 6789862
• Product Code: OLO
• UDI-Device Identifier: 00848486021849
• UDI-Public: 00848486021849
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K142530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2023

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: 204990
• Device Catalogue Number: 204990
• Device Lot Number: 40M153250 / 4002489
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2023
• Supplement Date Received by Manufacturer: 03/10/2023
• Initial Report FDA Received Date: 02/09/2023
• Supplement Report FDA Received Date: 03/23/2023
• 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