MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 27IN 0 S/A UR-5; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J376H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device le6736 batch number, and no non-conformances were identified.Attempts are being made to receive a device for evaluation.To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Was there any additional tissue damage as a result of searching for the needle piece? device return follow up.This medwatch report is in response to receipt of maude event report mw5093154.
Event or Problem Description
It was reported that the patient underwent an unknown procedure on (b)(6) 2020 and the suture was used.While closing the fascia, ¿snap" was heard and when pulling the suture out, only half of the needle was still attached.Since unable to visualize the broken needle within the incision, fluoroscopy was performed, and the identified needle was removed.There were no patient consequences reported.Additional information has been requested.

• Brand Name: VCL CT BRD VIO 27IN 0 S/A UR-5
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9931814
• Report Number: 2210968-2020-02695
• Device Sequence Number: 14069492
• Product Code: GAM
• UDI-Device Identifier: 10705031039438
• UDI-Public: 10705031039438
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/10/2020

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 Expiration Date: 04/30/2022
• Device Model Number: J376H
• Device Catalogue Number: J376H
• Device Lot Number: LE6736
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2020
• Initial Report FDA Received Date: 04/06/2020
• Patient Sequence Number: 1