MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP ZIP 8I SURGICAL SKIN CLOSURE DEVICE; TAPE AND BANDAGE, ADHESIVE

Catalog Number	PS2080
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes 2 malfunction events in which the device was reportedly difficult to open or close.2 events had an additional device required to complete the procedure.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events 2 events were reported for this quarter.Product return status 2 devices were not available for evaluation.Additional information 2 devices were labeled for single-use.2 devices were not reprocessed or reused.Device not returned.

• Brand Name: ZIP 8I 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: 19116082
• Report Number: 3015967359-2024-00936
• Device Sequence Number: 15221833
• Product Code: KGX
• UDI-Device Identifier: 10865379000009
• UDI-Public: 10865379000009
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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
• Report Date (Section B): 04/16/2024

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
• Device Catalogue Number: PS2080
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2024
• Initial Report FDA Received Date: 04/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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