MAUDE Adverse Event Report: MAKO SURGICAL CORP. REAMER HANDLE OFFSET; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	212760
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Screws fell out of reamer case type / application: tha 4.1 - (if applicable) will device be decontaminated? device(s) will be decontaminated prior to return.
Additional 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 if additional information becomes available.
Additional Manufacturer Narrative
Reported event an event regarding disassociation involving a mako reamer handle was reported.The event was confirmed.Method & results -product evaluation and results: visual inspection confirmed the reported event.The reamer handle is missing screws that secure the two halves of the shell.There was no evidence of misuse or material deformation that would indicate anything beyond normal use.According to the relevant instructions for use, users are instructed to inspect the instruments prior to use to determine the ¿end of useful¿ life.One of the commonly identified failure modes that the user should inspect for is dissociation of screws in the 212760 offset reamer handle.This is shown on page 38 of the guide.-clinician review: no medical records were received for review with a clinical consultant.-product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there are no other complaints with a similar failure mode for this lot.Conclusions: 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
Screws fell out of reamer case type / application: tha 4.1 - (if applicable) will device be decontaminated? device(s) will be decontaminated prior to return.Update 01/october/2024 : as reported via medsun #(b)(4): stryker mako acetabular inserter missing 1 screw with several (~2) loose screws.This was used x2 today during hip replacements.Or nurse director alerted by spd director who noticed screw was missing after the procedures.
Additional Manufacturer Narrative
H10 updated to add medsun (fda) report (b)(4).
Event or Problem Description
Screws fell out of reamer.Case type / application: tha 4.1 - (if applicable) will device be decontaminated? device(s) will be decontaminated prior to return.Update 01/october/2024: as reported via medsun # (b)(4): stryker mako acetabular inserter missing 1 screw with several (~2) loose screws.This was used x2 today during hip replacements.Or nurse director alerted by spd director who noticed screw was missing after the procedures.

• Brand Name: REAMER HANDLE OFFSET
• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20181233
• Report Number: 3005985723-2024-00152
• Device Sequence Number: 20093832
• Product Code: OLO
• UDI-Device Identifier: 00848486032142
• UDI-Public: 00848486032142
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K170593
• 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,Followup
• Report Date (Section B): 01/06/2025

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 Catalogue Number: 212760
• Device Lot Number: 5601843
• 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: 08/15/2024
• Supplement Date Received by Manufacturer: 09/30/2024; 01/06/2025
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 10/21/2024; 01/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/26/2023
• 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