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 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 134 events for the failure: overheating of device, 23 events had insufficient information, 93 events had problem identified during non-clinical procedure; there was no patient involvement, 18 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, 134 events were reported for this quarter.Product return status, 27 devices were evaluated based on historical data analysis, 96 devices had investigation types that have not yet been determined, 11 devices were received.Evaluation findings (results/components), 27 devices: degradation problem identified, wear problem, lubrication problem identified, overheating problem identified / part/component/sub-assembly term not applicable, 96 devices: results pending completion of investigation / part/component/sub-assembly term not applicable, 10 devices: no device problem found / part/component/sub-assembly term not applicable, 1 device: wear problem, no device problem found / rod/shaft product disposition, 30 devices: archived by stryker, 6 devices: product not received, 2 devices: scrapped by stryker, 96 devices: product disposition is not yet determined.Additional information, 134 devices were not labeled for single-use, 134 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 # 3015967359-2025-99490.Supplemental rationale: corrected data: b5, h1, h6, h11.134 events were previously reported during the reporting quarter: however, - 1 event was reported in error.- 133 previously reported events are included in this follow-up record.Product return status: 51 devices were received.72 devices were evaluated based on historical data analysis.9 devices had investigation types that have not yet been determined.1 device was not available for evaluation.Evaluation findings (results/components): 37 devices: no device problem found / part/component/sub-assembly term not applicable.72 devices: degradation problem identified, wear problem, lubrication problem identified, overheating problem identified / part/component/sub-assembly term not applicable.3 devices: wear problem, no device problem found / rod/shaft.9 devices: results pending completion of investigation / part/component/sub-assembly term not applicable.4 devices: degradation problem identified, overheating problem identified / bearings.2 devices: lubrication problem identified, overheating problem identified / bearings.1 device: degradation problem identified / bearings.1 device: wear problem, lubrication problem identified, overheating problem identified / part/component/sub-assembly term not applicable.2 devices: wear problem, overheating problem identified / bearings.1 device: no findings available / part/component/sub-assembly term not applicable.1 device: degradation problem identified, no device problem found / bearings.Product disposition: 90 devices: scrapped by stryker.24 devices: archived by stryker.9 devices: product not received.1 device: scrapped by customer.9 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 july 1 ¿ september 30 2025.This report summarizes 133 events for the failure: overheating of device.- 97 events had problem identified during non-clinical procedure; there was no patient involvement.- 33 events had no health consequences or impact.- 3 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 # 3015967359-2025-99490.Supplemental rationale corrected data: b5, h1, h6, h11.133 events were previously reported during the reporting quarter; however, - 1 event was reported in error.- 132 previously reported events are included in this follow-up record.Product return status: 56 devices were received.75 devices were evaluated based on historical data analysis.1 device was not available for evaluation.Evaluation findings (results/components): 40 devices: no device problem found / part/component/sub-assembly term not applicable 75 devices: degradation problem identified, wear problem, lubrication problem identified, overheating problem identified / part/component/sub-assembly term not applicable 4 devices: wear problem, no device problem found / rod/shaft 4 devices: degradation problem identified, overheating problem identified / bearings 2 devices: lubrication problem identified, overheating problem identified / bearings 1 device: degradation problem identified / bearings 1 device: wear problem, lubrication problem identified, overheating problem identified / part/component/sub-assembly term not applicable 3 devices: wear problem, overheating problem identified / bearings 1 device: no findings available / part/component/sub-assembly term not applicable 1 device: degradation problem identified, no device problem found / bearings.Product disposition 96 devices: scrapped by stryker 25 devices: archived by stryker 9 devices: product not received 2 devices: 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 132 events for the failure: overheating of device.- 97 events had problem identified during non-clinical procedure; there was no patient involvement.- 34 events had no health consequences or impact.- 1 event had insufficient information.

• 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: 23399822
• Report Number: 3015967359-2025-99490
• Device Sequence Number: 9872116
• 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: 132
• 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: 09/30/2025
• Supplement Date Received by Manufacturer: 09/30/2025; 09/30/2025
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 01/27/2026; 04/24/2026
• 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