MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO ZIP 16 SURGICAL SKIN CLOSURE DEVICE; TAPE AND BANDAGE, ADHESIVE

Catalog Number	PS1160
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Codes	Wound Dehiscence (1154); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the device was not closing the wound after a procedure.There was no patient involvement, no delay, no medical intervention, and no adverse consequences.
Event or Problem Description
The user facility reported that the device was not closing the wound after a procedure.The zip was removed and the wound required sutures to be used.No other adverse consequences were reported.
Additional Manufacturer Narrative
H3 other text: device not returned.
Event or Problem Description
The user facility reported that the device was not closing the wound after a procedure.The zip was removed and the wound required sutures to be used.

• Brand Name: ZIP 16 SURGICAL SKIN CLOSURE DEVICE
• Common Device Name: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: zach baker ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 12601479
• Report Number: 3015967359-2021-02135
• Device Sequence Number: 3191934
• Product Code: KGX
• UDI-Device Identifier: 10865379000016
• UDI-Public: 10865379000016
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup,Followup
• Report Date (Section B): 12/06/2021

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: PS1160
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/15/2021
• Supplement Date Received by Manufacturer: 12/02/2021; 12/06/2021
• Initial Report FDA Received Date: 10/08/2021
• Supplement Report FDA Received Date: 12/02/2021; 12/06/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown