MAUDE Adverse Event Report: Stryker Instruments-a division of Stryker Corp Reamer; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Catalog Number	4100231000
Medical Device Problem Code	Material Disintegration (1177)
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 1 event was reported for this quarter.Product return status (b)(4) device investigation type has not yet been determined.Evaluation findings (results/components) (b)(4) device: results pending completion of investigation / part/component/sub-assembly term not applicable product disposition (b)(4) device: product disposition is not yet determined additional information (b)(4) device was not labeled for single-use.(b)(4) device was 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 1 event for the failure: material disintegration.- 1 event had problem identified during non-clinical procedure; there was no patient involvement.
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 # 3015967359-2025-99453.Supplemental rationale corrected data: b5, h6, h11.1 previously reported event was included in this follow-up record.Product return status 1 device was not available for evaluation.Evaluation findings (results/components) 1 device: no findings available / part/component/sub-assembly term not applicable.Product disposition.1 device: product not received.

• Brand Name: 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 ; +1(269)323-7700
• MDR Report Key: 23399774
• Report Number: 3015967359-2025-99453
• Device Sequence Number: 10047086
• Product Code: HWE
• UDI-Device Identifier: 04546540068224
• UDI-Public: 04546540068224
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/31/2026

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: 4100231000
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• 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: 04/24/2026; 07/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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