MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP ZIP 16 SURGICAL SKIN CLOSURE DEVICE; TAPE AND BANDAGE, ADHESIVE

Catalog Number	PS1160
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, 13 events were reported for this quarter.Product return status, 10 devices had investigation types that have not yet been determined, 3 devices were received.Evaluation findings (results/components), 13 devices: results pending completion of investigation / part/component/sub-assembly, term not applicable.Product disposition, 13 devices: product disposition is not yet determined.Additional information, 13 devices were labeled for single-use, 13 devices were 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 13 events for the failure: difficult to open or close, 3 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 # 3015967359-2025-99429.Supplemental rationale: corrected data: b5, h1, h6, h11.13 events were previously reported during the reporting quarter: however, - 2 previously reported events were included under mfr report # 3015967359-2025-99424 but should be included under this report.- 15 previously reported events are included in this follow-up record.Product return status: 9 devices were not available for evaluation.4 devices were received.1 device was evaluated using data provided by the user or third party.1 device investigation type has not yet been determined.Evaluation findings (results/components): 9 devices: no findings available / part/component/sub-assembly term not applicable.4 devices: mechanical problem identified / locking mechanism.1 device: stress problem identified / adhesive.1 device: results pending completion of investigation / part/component/sub-assembly term not applicable.Product disposition: 10 devices: product not received.4 devices: returned to supplier / vendor.1 device: 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 july 1 ¿ september 30 2025.This report summarizes 15 events for the failure: difficult to open or close.- 15 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 # 3015967359-2025-99429.Supplemental rationale: corrected data: b5, h1, h6, h11.15 events were previously reported during the reporting period; however, - 1 previously reported event in this report should have been included under mfr report # 3015967359-2025-99475.- 14 previously reported events are included in this follow-up record.Product return status 9 devices were not available for evaluation.4 devices were received.1 device was evaluated using data provided by the user or third party.Evaluation findings (results/components): 9 devices: no findings available / part/component/sub-assembly term not applicable.4 devices: mechanical problem identified / locking mechanism.1 device: stress problem identified / adhesive.Product disposition: 10 devices: product not received.4 devices: returned to supplier / vendor.
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 14 events for the failure: difficult to open or close.- 14 events had no health consequences or impact.

• Brand Name: ZIP 16 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: 23399791
• Report Number: 3015967359-2025-99429
• Device Sequence Number: 10047574
• Product Code: KGX
• UDI-Device Identifier: 00865379000019
• UDI-Public: 00865379000019
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 14
• 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: PS1160
• 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): 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