MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP SYSTEM 9 LARGE ASEPTIC HOUSING; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	9126120000
Medical Device Problem Code	Difficult to Open or Close (2921)
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: 1 device investigation type has not yet been determined.Additional information: 1 device was not reprocessed or reused.
Event or Problem Description
This report summarizes 1 event for the failure: difficult to open or close.1 event had problem identified during non-clinical procedure; there was no patient involvement.
Additional Manufacturer Narrative
On 9/19/2025 stryker instruments discontinued the practice of filing mdrs for complaints related to the aseptic battery housing being difficult to open or close for devices registered under hwe product code in according to fda's "final guidance on medical device reporting for manufacturers" section 2.15.This malfunction has not caused or contributed to any serious injuries or deaths in at least two years.No new mdrs will be filed for this malfunction and corrected supplemental mdrs will be submitted if necessary for any events pending device investigation.Following is the final vmsr supplemental update for this record: this record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Mfr report # 3015967359-2025-99122.Supplemental rationale: corrected data: h6, h11, 1 event was previously reported during the reporting period.Product return status 1 device was received.Evaluation findings (results/components) 1 device: no device problem found 213 / part/component/sub-assembly term not applicable | 4755.Product disposition: 1 device: serviced and returned to customer.Additional information: 1 device was not labeled for single-use.1 device was not reprocessed or reused.
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.Supplemental rationale: corrected data: b5, h6, h11.1 event was previously reported during the reporting quarter: however, - 1 event was reported in error.- 0 previously reported events are included in this follow-up record.Additional information: on 9/19/2025 stryker instruments discontinued the practice of filing mdrs for complaints related to cracked/fractured/broken aseptic battery housing for devices registered under hwe product code in according to fda's "final guidance on medical device reporting for manufacturers" section 2.15.This malfunction has not caused or contributed to any serious injuries or deaths in at least two years.No new mdrs will be filed for this malfunction and corrected supplemental mdrs will be submitted if necessary for any events pending device investigation.Following is the final vmsr supplemental update for this record: this record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Mfr report #.Supplemental rationale: corrected data: h6, h11, 1 event was previously reported during the reporting period.Product return status 1 device was received.Evaluation findings (results/components) 1 device: no device problem found | 213 / part/component/sub-assembly term not applicable | 4755.Product disposition: 1 device: serviced and returned to customer.Additional information: 1 device was not labeled for single-use.1 device was not reprocessed or reused.
Event or Problem Description
This report summarizes 0 events for the failure: difficult to open or close.

• Brand Name: SYSTEM 9 LARGE ASEPTIC HOUSING
• 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: 22646523
• Report Number: 3015967359-2025-99122
• Device Sequence Number: 8827938
• Product Code: HWE
• UDI-Device Identifier: 07613327482669
• UDI-Public: 07613327482669
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,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: 9126120000
• 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; 06/30/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 09/19/2025; 10/30/2025
• 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