MAUDE Adverse Event Report: STRYKER IRELAND LTD., INSTRUMENTS DIVISION MAKO REAMER; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	212760
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During right total hip it was noticed that a screw from the mako reamer handle had a screw missing.Xray taken to confirm screws not in surgical sight.Screws were found outside of operative site.This has happened 2 times.Reference report#: mw5169546.

• Brand Name: MAKO REAMER
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER IRELAND LTD., INSTRUMENTS DIVISION
• MDR Report Key: 21918326
• Report Number: MW5169545
• Device Sequence Number: 3873804
• Product Code: OLO
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/22/2025

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 Model Number: 212760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2025
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/28/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HIP IMPLANT & SCREWS.
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 127 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White