MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP ELITE 12CM ANGLED ATTACHMENT; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Catalog Number	5407120472
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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: 23 events were reported for this quarter.Product return status: 23 devices were evaluated in the field.Additional information: 23 devices were not labeled for single-use.23 devices were not reprocessed or reused.
Event or Problem Description
This report summarizes 23 events for the failure: flaked.23 events had problem identified during non-clinical procedure; there was no patient involvement.
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, h1, h6, h11.23 events were originally reported for this failure mode during the reporting quarter; however, - 2 events were inadvertently excluded.- 25 reported events are included in this follow-up record.Product return status: 1 device was received.1 device investigation type has not yet been determined.23 devices were evaluated in the field.Additional information: 25 devices were not labeled for single-use.25 devices were not reprocessed or reused.
Event or Problem Description
This report summarizes 25 events for the failure: flaked.- 24 events had problem identified during non-clinical procedure; there was no patient involvement.- 1 event had insufficient information.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Mfr report # 3015967359-2025-99004.Supplemental rationale, corrected data: b5, h6, h11.25 previously reported events were included in this follow-up record.Product return status.24 devices were evaluated in the field.1 device investigation type has not yet been determined.Evaluation findings (results/components).24 devices: material and/or chemical problem identified / coating material.1 device: results pending completion of investigation / part/component/sub-assembly term not applicable.Product disposition.1 device: scrapped by stryker.24 devices: product disposition is not yet determined.
Event or Problem Description
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Events occurred between april 1 ¿ june 30, 2025.This report summarizes 25 events for the failure: flaked.- 24 events had problem identified during non-clinical procedure; there was no patient involvement.- 1 event had insufficient information.
Event or Problem Description
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Events occurred between april 1 ¿ june 30 2025.This report summarizes 25 events for the failure: flaked.- 25 events had problem identified during non-clinical procedure; there was no patient involvement.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Mfr report # 3015967359-2025-99004 supplemental rationale.Corrected data: b5, h6, h11.25 previously reported events were included in this follow-up record.Product return status.24 devices were evaluated in the field.1 device was received.Evaluation findings (results/components).25 devices: material and/or chemical problem identified / coating material.Product disposition.23 devices: scrapped by stryker.

• Brand Name: ELITE 12CM ANGLED ATTACHMENT
• 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-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: kelsey barla ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 22586828
• Report Number: 3015967359-2025-99004
• Device Sequence Number: 13081995
• Product Code: HBE
• UDI-Device Identifier: 07613327096576
• UDI-Public: 07613327096576
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 25
• 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): 01/29/2026

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: 5407120472
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/30/2025
• Supplement Date Received by Manufacturer: 06/30/2025; 06/30/2025; 06/30/2025
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 07/31/2025; 10/30/2025; 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown