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	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes 19 events for the failure: detachment of device or device component.15 events had problem identified during non-clinical procedure; there was no patient involvement.3 events had no health consequences or impact.1 event 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.Reported events: 19 events were reported for this quarter.Product return status: 16 devices were received.3 devices had investigation types that have not yet been determined.Additional information: 19 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 # 3015967359-2025-99156.Supplemental rationale, corrected data: b5, h6, h11.19 previously reported events were included in this follow-up record.Product return status.16 devices were received.3 devices were not available for evaluation.Evaluation findings (results/components) 3 devices: fracture problem / bearings 3 devices: no findings available / part/component/sub-assembly term not applicable 9 devices: wear problem / bearings 1 device: degradation problem identified / device ingredient or reagent 2 devices: no device problem found / part/component/sub-assembly term not applicable 1 device: degradation problem identified / bearings product disposition 15 devices: scrapped by stryker 3 devices: product not received 1 device: scrapped by customer.
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 april 1 ¿ june 30, 2025.This report summarizes 19 events for the failure: detachment of device or device component.- 15 events had problem identified during non-clinical procedure; there was no patient involvement.- 3 events had no health consequences or impact.- 1 event had problem identified before clinical use/exposure; there was no patient involvement.

• 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: 22647064
• Report Number: 3015967359-2025-99156
• Device Sequence Number: 18312151
• 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: 19
• 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): 10/30/2025

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: 06/30/2025
• Supplement Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 10/30/2025
• 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