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	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that 2-3 days post op the patient presented with the zip device ripping and slipping out of place.The device was removed, and a new device was placed over the surgical site.

• 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: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 19660567
• Report Number: 3015967359-2024-01234
• Device Sequence Number: 17763205
• Product Code: KGX
• UDI-Device Identifier: 10865379000030
• UDI-Public: 10865379000030
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: PS1240
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 07/02/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown