MAUDE Adverse Event Report: TELEFLEX MEDICAL WECK EFX SHIELD PORT SITE CLOSURE SYSTEM; INSTRUMENT, LIGATURE PASSING A

Model Number	IPN914218
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
I wanted to bring it to the attention of the appropriate team an issue we experienced last night during a trial with product number efx002 and account 137700.I properly in-serviced the account, the surgeon, scrub tech and first assist in loading and using the efx002 weck shield fascial closure device.Upon entering the device into the patient defect, the suture retriever went down the first hole on the side to retrieve the suture which was done successfully.When the user went down the second hole to retrieve the second part of the suture, they were experiencing issues with retrieving the suture.The suture retriever bent where the metal sharp meets the plastic.I have attached pictures and videos.I do not have the product code to identify the actual batch or any specific information but i wanted to bring to the attention of our claims team that the device was faulty.
Event or Problem Description
I wanted to bring it to the attention of the appropriate team an issue we experienced last night during a trial with product number efx002 and account 137700.I properly in-serviced the account, the surgeon, scrub tech and first assist in loading and using the efx002 weck shield fascial closure device.Upon entering the device into the patient defect, the suture retriever went down the first hole on the side to retrieve the suture which was done successfully.When the user went down the second hole to retrieve the second part of the suture, they were experiencing issues with retrieving the suture.The suture retriever bent where the metal sharp meets the plastic.I have attached pictures and videos.I do not have the product code to identify the actual batch or any specific information but i wanted to bring to the the attention of our claims team that the device was faulty.
Additional Manufacturer Narrative
Qn# (b)(4).Review could not be performed as there was no specific lot number provided.Sample is not available for return , but photos were provided.Failure mode was recreated by our sme and it could not pass our suture retrieval test on one side.Per section 13.0 of mel-100232, 100% of devices go through the suture retrieval testing.If this device was bent , it would not have been able to pass our test and would be rejected.Although the defect was verified by photo, it is highly unlikely it left the mw facility in this condition based on 100% testing; therefore , the complaint is considered not valid.

• Brand Name: WECK EFX SHIELD PORT SITE CLOSURE SYSTEM
• Common Device Name: INSTRUMENT, LIGATURE PASSING A
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11819455
• Report Number: 3011137372-2021-00132
• Device Sequence Number: 16931220
• Product Code: HCF
• UDI-Device Identifier: 14026704645272
• UDI-Public: 14026704645272
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2021

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
• Operator of Device: Health Professional
• Device Model Number: IPN914218
• Device Catalogue Number: EFX002
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/27/2021
• Supplement Date Received by Manufacturer: 06/15/2021
• Initial Report FDA Received Date: 05/13/2021
• Supplement Report FDA Received Date: 06/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1