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 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.Reported events: 116 events were reported for this quarter.Product return status: 17 devices were received.88 devices were evaluated based on historical data analysis.11 devices had investigation types that have not yet been determined.Evaluation findings (results/components): 4 devices: degradation problem identified, overheating problem identified / bearings.88 devices: degradation problem identified, wear problem, lubrication problem identified, overheating problem identified / part/component/sub-assembly term not applicable.11 devices: results pending completion of investigation / part/component/sub-assembly.Term not applicable: 5 devices: lubrication problem identified, overheating problem identified / bearings.2 devices: degradation problem identified, no device problem found / part/component/sub-assembly term not applicable.5 devices: no device problem found / part/component/sub-assembly term not applicable.1 device: wear problem, overheating problem identified / bearings.Product disposition: 93 devices: scrapped by stryker.12 devices: product not received.11 devices: product disposition is not yet determined.Additional information: 116 devices were not labeled for single-use.116 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 october 1 ¿ december 31 2025.This report summarizes 116 events for the failure: overheating of device.92 events had problem identified during non-clinical procedure; there was no patient involvement.22 events had no health consequences or impact.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.Mfr report # 3015967359-2026-99004.Supplemental rationale corrected data: b5, h1, h6, h11 116 events were previously reported during the reporting quarter; however, 2 events were reported in error.114 previously reported events are included in this follow-up record.Product return status 22 devices were received.88 devices were evaluated based on historical data analysis.4 devices were not available for evaluation.Evaluation findings (results/components) 4 devices: degradation problem identified, overheating problem identified / bearings 88 devices: degradation problem identified, wear problem, lubrication problem identified, overheating problem identified / part/component/sub-assembly term not applicable 4 devices: no findings available / part/component/sub-assembly term not applicable 6 devices: lubrication problem identified, overheating problem identified / bearings 2 devices: degradation problem identified, no device problem found / part/component/sub-assembly term not applicable 6 devices: no device problem found / part/component/sub-assembly term not applicable 1 device: wear problem, overheating problem identified / bearings 1 device: wear problem, no device problem found / rod/shaft 2 devices: degradation problem identified, no device problem found / bearings.Product disposition 98 devices: scrapped by stryker 16 devices: product not received.
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 114 events for the failure: overheating of device.93 events had problem identified during non-clinical procedure; there was no patient involvement.19 events had no health consequences or impact.2 events had problem identified before clinical use/exposure; there was no patient involvement.

• 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: 24163064
• Report Number: 3015967359-2026-99004
• Device Sequence Number: 9204908
• 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: 114
• 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): 06/08/2026

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): Initial
• 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: 04/24/2026; 06/08/2026
• 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