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	Loss of or Failure to Bond (1068)
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.6 events were reported for this quarter.Product return status.1 device was not available for evaluation.4 devices had investigation types that have not yet been determined.1 device was evaluated using data provided by the user or third party.Evaluation findings (results/components).1 device: no findings available / part/component/sub-assembly term not applicable.4 devices: results pending completion of investigation / part/component/sub-assembly term not applicable.1 device: material and/or chemical problem identified / part/component/sub-assembly term not applicable.Product disposition.2 devices: product not received.4 devices: product disposition is not yet determined.Additional information.6 devices were labeled for single-use.6 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 6 events for the failure: loss of or failure to bond.- 6 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 # 3015967359-2025-99475.Supplemental rationale.Corrected data: b5, h6, h11.6 previously reported events were included in this follow-up record.Product return status: 3 devices were not available for evaluation.1 device was evaluated using data provided by the user or third party.2 devices had investigation types that have not yet been determined.Evaluation findings (results/components).2 devices: no findings available / part/component/sub-assembly term not applicable 1 device: malfunction observed without conclusive finding / part/component/sub-assembly term not applicable.1 device: material and/or chemical problem identified / part/component/sub-assembly term not applicable.2 devices: results pending completion of investigation / part/component/sub-assembly term not applicable.Product disposition.4 devices: product not received.2 devices: product disposition is not yet determined.
Event or Problem Description
No change.
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 7 events for the failure: loss of or failure to bond.- 7 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 # 3015967359-2025-99475.Supplemental rationale: corrected data: b5, h1, h6, h11.6 events were previously reported during the reporting quarter; however, - 1 previously reported event was included under mfr report # 3015967359-2025-99429 but should be included under this report.- 7 previously reported events are included in this follow-up record.Product return status 6 devices were not available for evaluation.1 device was evaluated using data provided by the user or third party.Evaluation findings (results/components) 2 devices: no findings available / part/component/sub-assembly term not applicable 1 device: malfunction observed without conclusive finding / part/component/sub-assembly term not applicable.1 device: material and/or chemical problem identified / part/component/sub-assembly term not applicable.3 devices: usage problem identified / part/component/sub-assembly term not applicable.Product disposition 7 devices: product not received.

• 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: 23399834
• Report Number: 3015967359-2025-99475
• Device Sequence Number: 10015032
• 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: 7
• 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