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	Biocompatibility (2886)
Health Effect - Clinical Codes	Rash (2033); Skin Inflammation/ Irritation (4545)
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.Evaluation findings (results/components) 1 device: results pending completion of investigation / part/component/sub-assembly term not applicable product disposition 1 device: product disposition is not yet determined additional information 1 device was labeled for single-use.1 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 october 1 ¿ december 31 2025.This report summarizes 1 event for the failure: biocompatibility.- 1 event had minor injury/illness/impairment.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Mfr report # 3015967359-2026-99100.Supplemental rationale.Corrected data: b5, h1, h6, h11.1 event was previously reported during the reporting quarter; however, - 1 previously reported event was included under mfr report # 3015967359-2026-99143 but should be included under this report.- 2 previously reported events are included in this follow-up record.Product return status.2 devices were not available for evaluation.Evaluation findings (results/components) 2 devices: usage problem identified / part/component/sub-assembly term not applicable.Product disposition.2 devices: product not received.
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 october 1 ¿ december 31 2025.This report summarizes 2 events for the failure: biocompatibility.- 2 events had no health consequences or impact.

• 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: 24163600
• Report Number: 3015967359-2026-99100
• Device Sequence Number: 9112382
• 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: 2
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,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: PS1240
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/31/2025
• Supplement Date Received by Manufacturer: 12/31/2025
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 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