MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP FOOTED ATTACHMENT 16MM; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Catalog Number	5407FA2000
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Codes	Burn(s) (1757); 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 january 1 ¿ march 31 2026.This report summarizes 50 events for the failure: overheating of device.- 38 events had problem identified during non-clinical procedure; there was no patient involvement.- 5 events had no health consequences or impact.- 6 events had problem identified before clinical use/exposure; there was no patient involvement.- 1 event had minor injury/illness/impairment.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events: 50 events were reported for this quarter.Product return status: 49 devices were evaluated based on historical data analysis.1 device was received.Evaluation findings (results/components): 49 devices: degradation problem identified, wear problem, lubrication problem identified, overheating problem identified / part/component/sub-assembly term not applicable.1 device: degradation problem identified, overheating problem identified / part/component/sub-assembly term not applicable.Product disposition: 27 devices: scrapped by stryker.23 devices: product not received.Additional information: 50 devices were not labeled for single-use.50 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 # 3015967359-2026-99196.Supplemental rationale corrected data: b5, h1, h6, h11 50 events were originally reported for this failure mode during the reporting quarter; however, - 3 events were inadvertently excluded.- 53 reported events are included in this follow-up record.Product return status 52 devices were evaluated based on historical data analysis.1 device was received.Evaluation findings (results/components): 52 devices: degradation problem identified, wear problem, lubrication problem identified, overheating problem identified / part/component/sub-assembly term not applicable 1 device: degradation problem identified, overheating problem identified / part/component/sub-assembly term not applicable.Product disposition: 30 devices: scrapped by stryker.23 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 january 1 ¿ march 31 2026.This report summarizes 53 events for the failure: overheating of device.- 41 events had problem identified during non-clinical procedure; there was no patient involvement.- 5 events had no health consequences or impact.- 6 events had problem identified before clinical use/exposure; there was no patient involvement.- 1 event had minor injury/illness/impairment.

• Brand Name: FOOTED ATTACHMENT 16MM
• 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: 24953796
• Report Number: 3015967359-2026-99196
• Device Sequence Number: 10029649
• Product Code: HBE
• UDI-Device Identifier: 07613327096392
• UDI-Public: 07613327096392
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 53
• 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): 04/27/2026

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: 5407FA2000
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/31/2026
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 04/22/2026
• Supplement Report FDA Received Date: 04/27/2026
• 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