MAUDE Adverse Event Report: ETHICON STRATAFIX SPIRAL PDO KNOTLESS TISSUE CONTROL DEVICE; SUTURE, SURGICAL, ABSORABLE

Catalog Number	SXPD2B202
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	04/05/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Dr.Brought patient to operating room for posterior cervical wound dehiscence.Patient had his original surgery approximately two weeks prior to dehiscence.Dr.Stated that they used four stratafix sutures to close the initial incision.The patient arrived to the office with wound dehiscence and was admitted to the hospital to repair the wound.A follow up needed to be done because doctors believe there is a defect with the new stratafix suture the hospital recently began to use.This product was brought in to replace the quill suture.

• Brand Name: STRATAFIX SPIRAL PDO KNOTLESS TISSUE CONTROL DEVICE
• Common Device Name: SUTURE, SURGICAL, ABSORABLE
• Manufacturer (Section D): ETHICON; route 22 west; po box 151; somerville NJ 08876
• MDR Report Key: 5652279
• Report Number: 5652279
• Device Sequence Number: 12327411
• Product Code: NEW
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/29/2016
• Report Date (Section F): 04/28/2016

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: Physician
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: SXPD2B202
• Device Lot Number: MDQX980
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/28/2016
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/13/2016
• 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: NO OTHER DEVICES
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 65 YR
• Date Report Sent to FDA: 04/28/2016