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	Overheating of Device (1437)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes 139 events for the failure: overheating of device.107 events had problem identified during non-clinical procedure; there was no patient involvement.14 events had no health consequences or impact.16 events had insufficient information.2 events had problem identified before clinical use/exposure; 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.Reported events: 139 events were reported for this quarter.Product return status: 121 devices were received.18 devices had investigation types that have not yet been determined.Additional information: 139 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 april 1 ¿ june 30, 2025.This report summarizes 139 events for the failure: overheating of device.- 119 events had problem identified during non-clinical procedure; there was no patient involvement.- 16 events had no health consequences or impact.- 2 events had problem identified before clinical use/exposure; there was no patient involvement.- 2 events 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 # 3015967359-2025-99136., supplemental rationale corrected data: b5, h6, h11.139 previously reported events were included in this follow-up record.Product return status, 132 devices were evaluated based on historical data analysis.6 devices were received.1 device investigation type has not yet been determined.Evaluation findings (results/components), 132 devices: degradation problem identified, wear problem, lubrication problem identified, overheating problem identified / part/component/sub-assembly term not applicable.3 devices: no device problem found / part/component/sub-assembly term not applicable.2 devices: maintenance problem identified, overheating problem identified / bearings.1 device: lubrication problem identified, overheating problem identified / device ingredient or reagent.1 device: results pending completion of investigation / part/component/sub-assembly term not applicable.Product disposition.34 devices: product not received.103 devices: scrapped by stryker.1 device: scrapped by customer.1 device: product disposition is not yet determined.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Mfr report # 3015967359-2025-99136.Supplemental rationale: corrected data: b5, h6, h11.139 previously reported events were included in this follow-up record.Product return status: 131 devices were evaluated based on historical data analysis.8 devices were received.Evaluation findings (results/components): 131 devices: degradation problem identified, wear problem, lubrication problem identified, overheating problem identified / part/component/sub-assembly term not applicable.3 devices: no device problem found / part/component/sub-assembly term not applicable.2 devices: maintenance problem identified, overheating problem identified / bearings.1 device: lubrication problem identified, overheating problem identified / device ingredient or reagent.2 devices: wear problem, overheating problem identified / bearings.Product disposition: 33 devices: product not received.105 devices: scrapped by stryker.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 april 1 ¿ june 30, 2025.This report summarizes 139 events for the failure: overheating of device.120 events had problem identified during non-clinical procedure; there was no patient involvement.16 events had no health consequences or impact.3 events had problem identified before clinical use/exposure; there was no patient involvement.
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 # 3015967359-2025-99136 supplemental rationale corrected data: b5, h6, h11 139 previously reported events were included in this follow-up record.Product return status 131 devices were evaluated based on historical data analysis.8 devices were received.Evaluation findings (results/components) 131 devices: degradation problem identified, wear problem, lubrication problem identified, overheating problem identified / part/component/sub-assembly term not applicable 3 devices: no device problem found / part/component/sub-assembly term not applicable 2 devices: maintenance problem identified, overheating problem identified / bearings 1 device: lubrication problem identified, overheating problem identified / device ingredient or reagent 2 devices: wear problem, overheating problem identified / bearings.Product disposition 33 devices: product not received 105 devices: scrapped by stryker 1 device: scrapped by customer.

• 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: 22646739
• Report Number: 3015967359-2025-99136
• Device Sequence Number: 18312278
• 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: 139
• 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): 04/29/2026

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: 07/29/2025
• Supplement Report FDA Received Date: 10/31/2025; 01/29/2026; 04/29/2026
• 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