MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 2.2MM LINDEMANN DRILL BIT; BUR, SURGICAL, GENERAL & PLASTIC SURGERY

Catalog Number	1608002043
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Insufficient Information (4580); 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: 6 events were reported for this quarter.Product return status: 6 device investigation types have not yet been determined.Additional information: 6 devices were labeled for single-use.6 devices were not reprocessed or reused.
Event or Problem Description
This report summarizes 6 malfunction events in which the device or cutting accessory fractured.1 event had patient involvement; no patient impact.5 events had insufficient information received.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale: 6 previously reported events are included in this follow-up record.Product return status: 2 devices were not available for evaluation.1 device was evaluated using data provided by the user or a third party.3 device investigation types have not yet been determined.
Event or Problem Description
This report summarizes 6 malfunction events in which the device or cutting accessory fractured.4 events had patient involvement; no patient impact.2 events had insufficient information received.
Event or Problem Description
This report summarizes 6 malfunction events in which the device or cutting accessory fractured.4 events had patient involvement: no patient impact.2 events had unexpected medical intervention.
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: 6 previously reported events are included in this follow-up record.Product return status: 5 devices were not available for evaluation.1 device was evaluated using data provided by the user or a third party.

• Brand Name: 2.2MM LINDEMANN DRILL BIT
• Common Device Name: BUR, SURGICAL, GENERAL & PLASTIC SURGERY
• 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: 19816876
• Report Number: 3015967359-2024-01325
• Device Sequence Number: 8679749
• Product Code: GFF
• UDI-Device Identifier: 04546540030597
• UDI-Public: 04546540030597
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 6
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/23/2025

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: 1608002043
• 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
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 10/25/2024; 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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