MAUDE Adverse Event Report: ETHICON INC. EB EXC GRN 30IN 2-0 D/A SH-2 + PLGT; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	PX82H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 07/17/2019.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported that a patient underwent a valve surgery on (b)(6) 2019 and suture was used.During the procedure, the suture pulled off the needle.Changed another one to complete surgery.There were no adverse patient consequences reported.No additional information could be provided.
Additional Manufacturer Narrative
Product complaint #: (b)(4).An opened sample of product code px82, was received for evaluation.The product code is double armed.During the visual inspection of the sample, the swage and attachment area were noted to be as expected.The barrel hole was examined under 20x magnification and remnant suture was noted and the suture end is severely cut (damaged), resulting in a clip off defect.The second needle no present defects.The manufacturing records couldn't be reviewed as the batch number is unknown.According to the sample conditions, the assignable cause of the detached needle is a clip off defect, this defect is caused by excessive pressure on the suture during swaging of the needle and consequently breaking and due to this condition.

• Brand Name: EB EXC GRN 30IN 2-0 D/A SH-2 + PLGT
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8799337
• Report Number: 2210968-2019-84406
• Device Sequence Number: 16853841
• Product Code: GAT
• UDI-Device Identifier: 10705031049253
• UDI-Public: 10705031049253
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2019

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 Catalogue Number: PX82H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2019
• Initial Date Received by Manufacturer: 06/20/2019
• Supplement Date Received by Manufacturer: 07/24/2019
• Initial Report FDA Received Date: 07/17/2019
• Supplement Report FDA Received Date: 08/20/2019
• Patient Sequence Number: 1