MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP ZIP 24 SURGICAL SKIN CLOSURE DEVICE; TAPE AND BANDAGE, ADHESIVE

Catalog Number	PS1240
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: 28 events were reported for this quarter.Product return status: 28 devices had investigation types that have not yet been determined.Additional information: 28 devices were not reprocessed or reused.
Event or Problem Description
This report summarizes 28 events for the failure: difficult to open or close.- 28 events 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.Mfr report # 3015967359-2025-99228.Supplemental rationale: corrected data: b5, h6, h11.28 previously reported events were included in this follow-up record.Product return status: 24 devices were not available for evaluation.4 devices had investigation types that have not yet been determined.Evaluation findings (results/components) 24 devices: no findings available / part/component/sub-assembly term not applicable 4 devices: results pending completion of investigation / part/component/sub-assembly term not applicable.Product disposition: 24 devices: product not received.4 devices: product disposition is not yet determined.
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 28 events for the failure: difficult to open or close.- 28 events had no health consequences or impact.
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 # 3015967359-2025-99228.Supplemental rationale: corrected data: b5, h6, h11.28 previously reported events were included in this follow-up record.Product return status: 24 devices were not available for evaluation.4 devices were received.Evaluation findings (results/components): 24 devices: no findings available / part/component/sub-assembly term not applicable.4 devices: mechanical problem identified / locking mechanism.Product disposition: 24 devices: product not received.4 devices: returned to supplier / vendor.

• Brand Name: ZIP 24 SURGICAL SKIN CLOSURE DEVICE
• Common Device Name: TAPE AND BANDAGE, ADHESIVE
• 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: 22648101
• Report Number: 3015967359-2025-99228
• Device Sequence Number: 8609533
• Product Code: KGX
• UDI-Device Identifier: 00865379000033
• UDI-Public: 00865379000033
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 28
• 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): 01/29/2026

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: PS1240
• 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: 10/30/2025; 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown