MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 2.3MM X 22.0MM TAPERED ROUTER; DRILLS, BURRS, TREPHINES & ACCESSORIES

Catalog Number	5130071223
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Device discarded.
Event or Problem Description
It was reported that during incoming inspection, a hole was identified in the packaging of the device.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
The device was not returned for investigation.The quality investigation is complete.
Event or Problem Description
It was reported that during incoming inspection, a hole was identified in the packaging of the device.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.

• Brand Name: 2.3MM X 22.0MM TAPERED ROUTER
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8089841
• Report Number: 0001811755-2018-02523
• Device Sequence Number: 1279618
• Product Code: HBE
• UDI-Device Identifier: 04546540079640
• UDI-Public: 04546540079640
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 12/21/2018

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: 08/01/2023
• Device Catalogue Number: 5130071223
• Device Lot Number: 18243017
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/30/2018
• Supplement Date Received by Manufacturer: 12/19/2018
• Initial Report FDA Received Date: 11/20/2018
• Supplement Report FDA Received Date: 12/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1