MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO FAN BLADE, OFFSET (53.0 X 0.64 X 40.0MM); BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL

Model Number	5400134285
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting device return.
Event or Problem Description
It was reported that the blade broke during a redo-sternotomy at the blade mount.It was also reported that there were no adverse consequences and a delay of two minutes as a result of this event.It was further reported that the procedure was completed successfully.
Additional Manufacturer Narrative
H6: the quality investigation is complete.
Event or Problem Description
It was reported that the blade broke during a redo-sternotomy at the blade mount.It was also reported that there were no adverse consequences and a delay of two minutes as a result of this event.It was further reported that the procedure was completed successfully.

• Brand Name: FAN BLADE, OFFSET (53.0 X 0.64 X 40.0MM)
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 10701230
• Report Number: 0001811755-2020-02721
• Device Sequence Number: 3934163
• Product Code: GFA
• UDI-Device Identifier: 04546540729675
• UDI-Public: 04546540729675
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2020

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 Expiration Date: 12/01/2024
• Device Model Number: 5400134285
• Device Catalogue Number: 5400134285
• Device Lot Number: 19337027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Initial Date Received by Manufacturer: 09/23/2020
• Supplement Date Received by Manufacturer: 09/23/2020
• Initial Report FDA Received Date: 10/19/2020
• Supplement Report FDA Received Date: 12/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1