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 Codes	Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Skin Inflammation/ Irritation (4545); Insufficient Information (4580)
Date of Event	09/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient experienced wound dehiscence underneath the zip surgical skin closure device.Attempts are being made to obtain additional information from the user facility.
Additional Manufacturer Narrative
Correction: update: d9, h3, h6.Follow-up report submitted to document the device was not available for evaluation.Additional manufacturing narractive.Update: b5.Additional event information.Update: d4.Lot number is not available, full gtin is not known.
Event or Problem Description
It was reported that the patient experienced wound dehiscence underneath the zip surgical skin closure device.The device was removed before the surgeon intended.The procedure was completed successfully without a surgical delay; ointment was applied to lessen inflammation.No adverse consequences were reported.

• 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: 20212193
• Report Number: 3015967359-2024-01796
• Device Sequence Number: 15404129
• Product Code: KGX
• UDI-Device Identifier: 10865379000016
• UDI-Public: (01)10865379000016
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: PS1160
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/05/2024
• Supplement Date Received by Manufacturer: 12/04/2024
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 12/04/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown