MAUDE Adverse Event Report: ZIPLINE MEDICAL ZIP 24 SURGICAL SKIN CLOSURE DEVICE; TAPE-BASED WOUND CLOSURE

Model Number	PS1240
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	03/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
See user facility voluntary emdr report number mw5085079.On pod 1, patient suffered a traumatic fall, resulting in failure of deep sutures and subsequent partial dehiscence of surgical incision under the zip device.Based upon patient photographic image, there is no evidence of device malfunction.
Event or Problem Description
Total knee arthroplasty patient was re-admitted to or for re-closure of surgical incision following a traumatic fall that resulted in failure of deep sutures and partial incision dehiscence.See voluntary report number mw5085079 generated by user facility.
Additional Manufacturer Narrative
The initial report documented the ps1243 zipseal 24 surgical skin closure convenience kit, which consists of the ps1240 zip 24 surgical skin closure device and the cardinal health topical skin adhesive, as the suspect medical device.Based upon the voluntary emdr report number mw5085079 and upon further investigation, the report has been corrected to indicate that the ps1240 zip 24 device is the suspect medical device and documents the skin adhesive as a concomitant product only.Accordingly, the following changes were made to form 3500a: d1: brand name: changed to zip 24 surgical skin closure device.D2: type of device: changed to product code kgx, which is assigned to the zip 24 surgical skin closure device.D4: additional device information: changed model number and catalog number to ps1240.Updated lot number to 0000110434.Updated expiration date to match expiration date of the zip device lot.Changed unique device identifier (udi) entry to (b)(4) for the zip device.D11: concomitant medical products and therapy dates: added cardinal health topical skin adhesive to list.H4: device manufacturer date: changed date to reflect manufacturing date of zip 24 lot#: 0000110434.

• Brand Name: ZIP 24 SURGICAL SKIN CLOSURE DEVICE
• Common Device Name: TAPE-BASED WOUND CLOSURE
• Manufacturer (Section D): ZIPLINE MEDICAL; 747 camden ave.; suite a; campbell CA 95008
• MDR Report Key: 8524232
• Report Number: 3009673389-2019-00003
• Device Sequence Number: 19303775
• Product Code: KGX
• UDI-Device Identifier: 00853114007232
• UDI-Public: 00853114007232
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: 510K EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/16/2021
• Device Model Number: PS1240
• Device Catalogue Number: PS1240
• Device Lot Number: 0000110434
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2019
• Supplement Date Received by Manufacturer: 03/19/2019
• Initial Report FDA Received Date: 04/17/2019
• Supplement Report FDA Received Date: 04/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARDINAL HEALTH TOPICAL SKIN ADHESIVE; SURGICAL STAPLES; SURGICAL STAPLES; SURGICAL STAPLES
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 154