MAUDE Adverse Event Report: Stryker Instruments-a division of Stryker Corp Elite 7cm Angled Attachment; Drills, Burrs, Trephines & Accessories (Simple, Powered)

Catalog Number	5407120452
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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.Mfr report # (b)(4).Supplemental rationale: corrected data: b5, h6, h11.3 previously reported events were included in this follow-up record.Product return status: 2 devices were not available for evaluation.1 device was received.Evaluation findings (results/components).2 devices: no findings available / part/component/sub-assembly term not applicable.1 device: wear problem / bearings.Product disposition: 2 devices: product not received.1 device: scrapped by stryker.

• Brand Name: Elite 7cm 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 ; +1(269)323-7700
• MDR Report Key: 25907602
• Report Number: 3015967359-2026-99376
• Device Sequence Number: 12880843
• Product Code: HBE
• UDI-Device Identifier: 07613327096552
• UDI-Public: 07613327096552
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 3
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2026

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: 5407120452
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2026
• Supplement Date Received by Manufacturer: 06/30/2026
• Initial Report FDA Received Date: 07/22/2026
• Supplement Report FDA Received Date: 09/23/2026
• 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