MAUDE Adverse Event Report: STRYKER CORP. MAKO TKA MICS ROBOTIC HANDPIECE (STRYKER); ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number ASSEMBLY NUMBER: 209063

Device Problems Material Fragmentation (1261); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Insufficient Information (4580)

Event Date 10/04/2020

Event Type  malfunction  

Event Description

Mako tka mics robotic handpiece (stryker) - debris was found to be within the handles of the handpiece after cleaning.The ifus for the device do not allow for the handles to be taken apart to be thoroughly cleaned and the vendor does not support us in doing so.Other mitigation efforts were not unsuccessful.Awaiting vendor resolution.Fda safety report id# (b)(4).

• Brand Name: MAKO TKA MICS ROBOTIC HANDPIECE (STRYKER)
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER CORP.
• MDR Report Key: 10755209
• MDR Text Key: 213886647
• Report Number: MW5097525
• Device Sequence Number: 1
• Product Code: OLO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 10/27/2020
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ASSEMBLY NUMBER: 209063
• Device Catalogue Number: ASSEMBLY NUMBER: 209063
• Device Lot Number: 42020919
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1