MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 4.0MM ROUND CARBIDE BUR; BUR, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	0277010240
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Device not available for return.
Event or Problem Description
It was reported that there was a potential sterility breach on the packaging of the device.It was also reported that it was noticed prior to a procedure and no patient involvement.It was further reported that there was no delay or adverse consequences as a result of this event.
Event or Problem Description
It was reported that there was a potential sterility breach on the packaging of the device.It was also reported that it was noticed prior to a procedure and no patient involvement.It was further reported that there was no delay or adverse consequences as a result of this event.
Additional Manufacturer Narrative
H6: the quality investigation is complete.H3 other text: device discarded by customer.

• Brand Name: 4.0MM ROUND CARBIDE BUR
• Common Device Name: BUR, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 11354191
• Report Number: 0001811755-2021-00622
• Device Sequence Number: 4117216
• Product Code: GFF
• UDI-Device Identifier: 04546540050557
• UDI-Public: 04546540050557
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2021

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: 11/01/2025
• Device Model Number: 0277010240
• Device Catalogue Number: 0277010240
• Device Lot Number: 20317017
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/03/2021
• Supplement Date Received by Manufacturer: 04/09/2021
• Initial Report FDA Received Date: 02/19/2021
• Supplement Report FDA Received Date: 04/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1