MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP AO LARGE REAMER; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	4100210000
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 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 4 events for the failure: detachment of device or device component.3 events had problem identified during non-clinical procedure; there was no patient involvement.1 event 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: 4 events were reported for this quarter.Product return status: 2 devices were received.2 devices had investigation types that have not yet been determined.Evaluation findings (results/components): 1 device: wear problem / mount, spring, 2 devices: results pending completion of investigation / part/component/sub-assembly term not applicable, 1 device: wear problem / spring.Product disposition: 2 devices: scrapped by stryker, 2 devices: product disposition is not yet determined.Additional information: 4 devices were not labeled for single-use.4 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 # 3015967359-2025-99456.Supplemental rationale: corrected data: b5, h6, h11.4 previously reported events were included in this follow-up record.Product return status: 3 devices were received.1 device investigation type has not yet been determined.Evaluation findings (results/components): 1 device: wear problem / mount, spring.1 device: wear problem / screw, pin, spring.1 device: wear problem / spring.1 device: results pending completion of investigation / part/component/sub-assembly term not applicable.Product disposition: 3 devices: scrapped by stryker.1 device: product disposition is not yet determined.
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 # 3015967359-2025-99456.Supplemental rationale: corrected data: b5, h1, h6, h11.4 events were previously reported during the reporting quarter; however, 1 event was reported in error.3 previously reported events are included in this follow-up record.Product return status: 3 devices were received.Evaluation findings (results/components).1 device: wear problem / mount, spring.1 device: wear problem / screw, pin, spring.1 device: wear problem / spring.Product disposition: 3 devices: scrapped by stryker.
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 3 events for the failure: detachment of device or device component.2 events had problem identified during non-clinical procedure; there was no patient involvement.1 event had no health consequences or impact.

• Brand Name: AO LARGE REAMER
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• 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: 23399766
• Report Number: 3015967359-2025-99456
• Device Sequence Number: 21327936
• Product Code: HWE
• UDI-Device Identifier: 04546540068217
• UDI-Public: 04546540068217
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 3
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,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: 4100210000
• 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; 09/30/2025
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 01/27/2026; 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