MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP ELITE 14CM ANGLED ATTACHMENT; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Catalog Number	5407120482
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Codes	Partial thickness (Second Degree) Burn (2694); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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 july 1 ¿ september 30 2025.This report summarizes 131 events for the failure: overheating of device.110 events had problem identified during non-clinical procedure; there was no patient involvement.-21 events had no health consequences or impact.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events 131 events were reported for this quarter.Product return status 62 devices were evaluated based on historical data analysis.37 devices were received.32 devices had investigation types that have not yet been determined.Evaluation findings (results/components) 62 devices: degradation problem identified, wear problem, lubrication problem identified, overheating problem identified / part/component/sub-assembly term not applicable 29 devices: no device problem found / part/component/sub-assembly term not applicable 2 devices: overheating problem identified / part/component/sub-assembly term not applicable 2 devices: lubrication problem identified, overheating problem identified / device ingredient or reagent 4 devices: degradation problem identified, overheating problem identified / bearings 32 devices: results pending completion of investigation / part/component/sub-assembly term not applicable product disposition: 86 devices: scrapped by stryker, 12 devices: product not received, 1 device: scrapped by customer, 32 devices: product disposition is not yet determined.Additional information: 131 devices were not labeled for single-use.131 devices were not reprocessed or reused.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Mfr report # 3015967359-2025-99464.Supplemental rationale: corrected data: b5, h6, h11.131 previously reported events were included in this follow-up record.Product return status: 90 devices were evaluated based on historical data analysis.41 devices were received.Evaluation findings (results/components): 90 devices: degradation problem identified, wear problem, lubrication problem identified, overheating problem identified / part/component/sub-assembly term not applicable.31 devices: no device problem found / part/component/sub-assembly term not applicable.2 devices: overheating problem identified / part/component/sub-assembly term not applicable.4 devices: lubrication problem identified, overheating problem identified / device ingredient or reagent.4 devices: degradation problem identified, overheating problem identified / bearings.Product disposition: (b)(4) devices: scrapped by stryker.19 devices: product not received.1 device: scrapped by customer.
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 july 1 ¿ september 30, 2025.This report summarizes 131 events for the failure: overheating of device.109 events had problem identified during non-clinical procedure; there was no patient involvement.22 events had no health consequences or impact.

• Brand Name: ELITE 14CM 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: 23399844
• Report Number: 3015967359-2025-99464
• Device Sequence Number: 10015040
• Product Code: HBE
• UDI-Device Identifier: 07613327096590
• UDI-Public: 07613327096590
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 131
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2026

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: 5407120482
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/30/2025
• Supplement Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 01/27/2026
• 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