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 Code	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.Mfr report # 3015967359-2026-99097.Supplemental rationale.Corrected data: h11.19 previously reported events were included in this follow-up record.Product return status.17 devices were evaluated in the field.2 devices had investigation types that have not yet been determined.Evaluation findings (results/components).17 devices: material and/or chemical problem identified / coating material.2 devices: results pending completion of investigation / part/component/sub-assembly term not applicable.Product disposition.17 devices: scrapped by stryker.2 devices: product disposition type not yet determined.
Event or Problem Description
No change.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events 19 events were reported for this quarter.Product return status 2 devices had investigation types that have not yet been determined.17 devices were evaluated in the field.Evaluation findings (results/components) 2 devices: results pending completion of investigation / part/component/sub-assembly term not applicable 17 devices: material and/or chemical problem identified / coating material product disposition 1 device: scrapped by stryker 18 devices: product disposition is not yet determined additional information 19 devices were not labeled for single-use.19 devices were not reprocessed or reused.
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 (b)(6) 2025.This report summarizes 19 events for the failure: flaked.- 19 events had problem identified during non-clinical procedure; there was no patient involvement.
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 october 1 ¿ december 31 2025.This report summarizes 18 events for the failure: flaked.18 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, h11.19 events were previously reported during the reporting quarter; however, 1 event was reported in error.18 previously reported events are included in this follow-up record.Product return status: 1 device was received.17 devices were evaluated in the field.Evaluation findings (results/components): 1 device: no device problem found / part/component/sub-assembly term not applicable.17 devices: material and/or chemical problem identified / coating material.Product disposition: 18 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: 24163594
• Report Number: 3015967359-2026-99097
• Device Sequence Number: 9129756
• 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: 18
• 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): 04/24/2026

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: 12/31/2025
• Supplement Date Received by Manufacturer: 12/31/2025; 12/31/2025
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 01/30/2026; 04/27/2026
• 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