MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 3.0MM CARBIDE MATCH HEAD; DRILLS, BURRS, TREPHINES & ACCESSORIES

Model Number	5820107530C
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2020
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 there was a potential sterility breach on the packaging of the device, particles were identified in the pack prior to a procedure.It was also reported that this event did not occur during a surgical procedure, and there was no delay or adverse consequences as a result of this event.
Additional Manufacturer Narrative
H6: the quality investigation is complete.
Event or Problem Description
It was reported that there was a potential sterility breach on the packaging of the device, particles were identified in the pack prior to a procedure.It was also reported that this event did not occur during a surgical procedure, and 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, particles were identified in the pack prior to a procedure.It was also reported that this event did not occur during a surgical procedure, and there was no delay or adverse consequences as a result of this event.
Additional Manufacturer Narrative
H6: the quality investigation is complete.

• Brand Name: 3.0MM CARBIDE MATCH HEAD
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 9875377
• Report Number: 0001811755-2020-00788
• Device Sequence Number: 11580290
• Product Code: HBE
• UDI-Device Identifier: 07613327294989
• UDI-Public: 07613327294989
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K143320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/09/2020

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: 09/01/2021
• Device Model Number: 5820107530C
• Device Catalogue Number: 5820107530C
• Device Lot Number: 19261017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Initial Date Received by Manufacturer: 03/02/2020
• Supplement Date Received by Manufacturer: 06/25/2020; 11/05/2020
• Initial Report FDA Received Date: 03/24/2020
• Supplement Report FDA Received Date: 08/11/2020; 11/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1