MAUDE Adverse Event Report: STRYKER GMBH STRYKER MAKO ROBOT SAGITTAL SAW ATTACHMENT RIGHT ANGLE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	42166
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Stryker mako robot saggital saw right angle attachment and straight sagittal saw attachment 2.7 breaking and unable to hold saw blade securely.Repairs and replacement required frequently.Risk to patient harm during procedure.Mfg ifu followed for processing.Ref report mw5153825.

• Brand Name: STRYKER MAKO ROBOT SAGITTAL SAW ATTACHMENT RIGHT ANGLE
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH
• MDR Report Key: 19104558
• Report Number: MW5153824
• Device Sequence Number: 18054211
• Product Code: OLO
• UDI-Device Identifier: 00848486032128
• UDI-Public: 00848486032128
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 04/10/2024

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
• Operator of Device: Health Professional
• Device Model Number: 42166
• Device Catalogue Number: 212480
• Device Lot Number: 35091123
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/12/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown