MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP ELITE 12CM STRAIGHT ATTACHMENT; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Catalog Number	5407120470
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	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 october 1 ¿ december 31 2025.This report summarizes 108 events for the failure: overheating of device.- 85 events had problem identified during non-clinical procedure; there was no patient involvement.- 2 events had problem identified before clinical use/exposure; 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 108 events were reported for this quarter.Product return status 67 devices were evaluated based on historical data analysis.27 devices were received.14 devices had investigation types that have not yet been determined.Evaluation findings (results/components).67 devices: degradation problem identified, wear problem, lubrication problem identified, overheating problem identified / part/component/sub-assembly term not applicable 15 devices: no device problem found / part/component/sub-assembly term not applicable (b)(4) devices: lubrication problem identified, overheating problem identified / bearings (b)(4) devices: wear problem, no device problem found / bearings (b)(4) devices: results pending completion of investigation / part/component/sub-assembly term not applicable (b)(4) devices: degradation problem identified, overheating problem identified / part/component/sub-assembly term not applicable (b)(4) devices: degradation problem identified, overheating problem identified / bearings (b)(4) device: wear problem, overheating problem identified / bearings product disposition (b)(4) devices: product not received (b)(4) devices: scrapped by stryker (b)(4) devices: archived by stryker (b)(4) devices: product disposition is not yet determined additional information 108 devices were not labeled for single-use.108 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 108 events for the failure: overheating of device.84 events had problem identified during non-clinical procedure; there was no patient involvement.2 events had problem identified before clinical use/exposure; there was no patient involvement.22 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.Mfr report#: 3015967359-2026-99008.Supplemental rationale.Corrected data: b5, h6, h11.108 previously reported events were included in this follow-up record.Product return status.67 devices were evaluated based on historical data analysis.32 devices were received.9 devices were not available for evaluation.Evaluation findings (results/components): 67 devices: degradation problem identified, wear problem, lubrication problem identified, overheating problem identified / part/component/sub-assembly term not applicable 19 devices: no device problem found / part/component/sub-assembly term not applicable 4 devices: lubrication problem identified, overheating problem identified / bearings 2 devices: wear problem, no device problem found / bearings 9 devices: no findings available / part/component/sub-assembly term not applicable 3 devices: degradation problem identified, overheating problem identified / part/component/sub-assembly term not applicable.3 devices: degradation problem identified, overheating problem identified / bearings.1 device: wear problem, overheating problem identified / bearings.Product disposition: 24 devices: product not received.81 devices: scrapped by stryker.3 devices: archived by stryker.

• Brand Name: ELITE 12CM STRAIGHT 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: 24163068
• Report Number: 3015967359-2026-99008
• Device Sequence Number: 9204911
• Product Code: HBE
• UDI-Device Identifier: 07613327096569
• UDI-Public: 07613327096569
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 108
• 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): 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: 5407120470
• 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
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 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