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 Codes	Loss of or Failure to Bond (1068); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that after using a zip surgical skin closure device the device lost adhesion and the zipper tore from the adhesive.There were no reported delays, medical intervention or adverse consequences reported with the event.
Additional Manufacturer Narrative
Correction: d9, h3, h6.Follow-up report submitted to document the device was not available for evaluation.Additional information: d4.Complete gtin has been added.
Event or Problem Description
The customer reported that after using a zip surgical skin closure device the device lost adhesion and the zipper tore from the adhesive.There were no reported delays, medical intervention or adverse consequences reported with the event.

• 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: 19889568
• Report Number: 3015967359-2024-01649
• Device Sequence Number: 20740262
• Product Code: KGX
• UDI-Device Identifier: 10865379000030
• UDI-Public: (01)10865379000030(10)00002(17)50668
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2025

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: PS1240
• Device Lot Number: 0000250668
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/12/2024
• Supplement Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 08/01/2024
• Supplement Report FDA Received Date: 01/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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