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); Difficult to Open or Close (2921)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	07/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Scrapped.
Event or Problem Description
The user facility reported that the device lost adhesion on the wound after a procedure.Portion of the zip device had to be removed and replaced with sutures.
Event or Problem Description
The user facility reported that the device lost adhesion on the wound after a procedure.Portion of the zip device had to be removed and replaced with sutures.
Additional Manufacturer Narrative
Scrapped.

• 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: 15221686
• Report Number: 3015967359-2022-01623
• Device Sequence Number: 6729850
• Product Code: KGX
• UDI-Device Identifier: 10865379000030
• UDI-Public: 10865379000030
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Report Date (Section B): 09/15/2022

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: UNAVAILABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/02/2022
• Supplement Date Received by Manufacturer: 09/13/2022
• Initial Report FDA Received Date: 08/12/2022
• Supplement Report FDA Received Date: 09/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown