MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 1.1MM X 6.0MM STRAIGHT ROUTER; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Catalog Number	5820070011
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events 1 event was reported for this quarter.Product return status 1 device investigation type has not yet been determined.Additional information 1 device was labeled for single-use.1 device was not reprocessed or reused.
Event or Problem Description
This report summarizes 1 malfunction event in which the device was reported found to have a tear, rip, or hole in the device packaging.- 1 event had no patient involvement; no patient impact.
Event or Problem Description
This report summarizes 3 malfunction events in which the device was reported found to have a tear, rip, or hole in the device packaging.3 events had no patient involvement; no patient impact.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale: 1 event was originally reported for this failure mode during the reporting quarter; however, 2 events were inadvertently excluded.3 reported events are included in this follow-up record.Product return status: 3 device investigation types have not yet been determined.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale: 3 previously reported events are included in this follow-up record.Product return status: 3 device investigation types have not yet been determined.
Event or Problem Description
This report summarizes 3 malfunction events in which the device was reportedly received in such a manner to indicate that its sterility had been compromised.3 events had no patient involvement; no patient impact.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale corrected data: b5, h6, h11 3 previously reported events are included in this follow-up record.Product return status 3 devices were not available for evaluation.
Event or Problem Description
This report summarizes 3 malfunction events in which the device was reportedly received in such a manner to indicate that its sterility had been compromised.- 3 events had the problem identified during a non-clinical procedure; there was no patient involvement.

• Brand Name: 1.1MM X 6.0MM STRAIGHT ROUTER
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-IRELAND; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA
• Manufacturer Contact: kelsey barla ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 19818504
• Report Number: 3015967359-2024-01369
• Device Sequence Number: 8665499
• Product Code: HBE
• UDI-Device Identifier: 04546540362391
• UDI-Public: 04546540362391
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 3
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/27/2025

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
• Device Catalogue Number: 5820070011
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/30/2024
• Supplement Date Received by Manufacturer: 06/30/2024; 06/30/2024; 06/30/2024
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 07/31/2024; 10/25/2024; 01/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown