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

Catalog Number	5407120452
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
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events, 41 events were reported for this quarter.Product return status, 36 devices were evaluated based on historical data analysis, 2 devices were received, 3 devices had investigation types that have not yet been determined.Evaluation findings (results/components), 36 devices: degradation problem identified, wear problem, lubrication problem identified, overheating problem identified / part/component/sub-assembly term not applicable 1 device: wear problem, no device problem found / bearings, 3 devices: results pending completion of investigation / part/component/sub-assembly term not applicable, 1 device: wear problem, overheating problem identified / bearings.Product disposition, 37 devices: product not received, 2 devices: scrapped by stryker, 2 devices: product disposition is not yet determined.Additional information, 41 devices were not labeled for single-use, 41 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 41 events for the failure: overheating of device, 14 events had no health consequences or impact, 26 events had problem identified during non-clinical procedure; there was no patient involvement, 1 event had insufficient information.
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 # 3015967359-2025-99454.Supplemental rationale: corrected data: b5, h6, h11.41 previously reported events were included in this follow-up record.Product return status: 36 devices were evaluated based on historical data analysis.2 devices were received.3 devices were not available for evaluation.Evaluation findings (results/components): 36 devices: degradation problem identified, wear problem, lubrication problem identified, overheating problem identified / part/component / sub-assembly term not applicable.1 device: wear problem, no device problem found / bearings.3 devices: no findings available / part/component/sub-assembly term not applicable.1 device: wear problem, overheating problem identified / bearings.Product disposition: 39 devices: product not received.2 devices: scrapped by stryker.

• Brand Name: ELITE 7CM 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: 23399765
• Report Number: 3015967359-2025-99454
• Device Sequence Number: 18637814
• Product Code: HBE
• UDI-Device Identifier: 07613327096552
• UDI-Public: 07613327096552
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 41
• 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: 5407120452
• 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