MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP ELITE 7CM STRAIGHT ATTACHMENT; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Catalog Number	5407120450
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 85 events were reported for this quarter.Product return status 21 devices were received.42 devices were evaluated based on historical data analysis.22 devices had investigation types that have not yet been determined.Evaluation findings (results/components) 3 devices: degradation problem identified, overheating problem identified / bearings 13 devices: no device problem found / part/component/sub-assembly term not applicable 42 devices: degradation problem identified, wear problem, lubrication problem identified, overheating problem identified / part/component/sub-assembly term not applicable 2 devices: wear problem, no device problem found / bearings 22 devices: results pending completion of investigation / part/component/sub-assembly term not applicable 1 device: degradation problem identified, wear problem, no device problem found / bearings 2 devices: degradation problem identified, wear problem, overheating problem identified / bearings product disposition 41 devices: scrapped by stryker 22 devices: product not received 22 devices: product disposition is not yet determined additional information 85 devices were not labeled for single-use.85 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 july 1 ¿ september 30 2025.This report summarizes 85 events for the failure: overheating of device.- 62 events had problem identified during non-clinical procedure; there was no patient involvement.- 19 events had no health consequences or impact.- 4 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 #.Supplemental rationale: corrected data: b5, h6, h11.85 previously reported events were included in this follow-up record.Product return status: 24 devices were received.61 devices were evaluated based on historical data analysis.Evaluation findings (results/components): 3 devices: degradation problem identified, overheating problem identified / bearings.14 devices: no device problem found / part/component/sub-assembly term not applicable.61 devices: degradation problem identified, wear problem, lubrication problem identified, overheating problem identified / part/component/sub-assembly term not applicable 2 devices: wear problem, no device problem found / bearings.2 devices: degradation problem identified, wear problem, no device problem found / bearings.2 devices: degradation problem identified, wear problem, overheating problem identified / bearings.1 device: wear problem, overheating problem identified / bearings.Product disposition: 60 devices: scrapped by stryker.25 devices: product not received.
Event or Problem Description
No change.

• Brand Name: ELITE 7CM 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: 23399836
• Report Number: 3015967359-2025-99466
• Device Sequence Number: 10015034
• Product Code: HBE
• UDI-Device Identifier: 07613327096545
• UDI-Public: 07613327096545
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 85
• 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: 5407120450
• 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