MAUDE Adverse Event Report: ETHICON INC. EB EXC 5GRN/5WHT 30IN 2-0 D/A V-5 10PLGT; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Catalog Number	SXX54
Medical Device Problem Codes	Material Frayed (1262); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 an unknown procedure on (b)(6) 2019 and suture was used.The suture was fraying and the needle was popping off the suture.It was not reported how the procedure was completed.There was a short delay in the procedure.There were no patient consequences reported.
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot peu034, and no non-conformances were identified.Additional investigation summary: an opened msda folder with six strands double armed, a dispensed suture and five suture pieces of product code sxx54, lot # peu034 were received for evaluation.During the visual inspection of a dispensed suture and five suture pieces, the ends were noted cut and appears to be caused due to use of a surgical instrument and no fraying was noted on the surface suture.In handling this or any other suture material, care should be taken to avoid damage from handling.Avoid crushing or crimping damage due to application of surgical instruments such as forceps or needle holders.During the visual inspection of the six strands, the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along of the strand and no defects, damaged or fraying were observed.A functional test was performed and the pull force were above the minimum requirements.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the sample received no fraying sutures were noted and, the assignable cause of the performance pull off suture needle is an improper handling.

• Brand Name: EB EXC 5GRN/5WHT 30IN 2-0 D/A V-5 10PLGT
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9288078
• Report Number: 2210968-2019-89639
• Device Sequence Number: 16732349
• Product Code: GAT
• UDI-Device Identifier: 10705031050716
• UDI-Public: 10705031050716
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2019

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 Expiration Date: 04/30/2024
• Device Catalogue Number: SXX54
• Device Lot Number: PEU034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2019
• Initial Date Received by Manufacturer: 10/11/2019
• Supplement Date Received by Manufacturer: 11/13/2019
• Initial Report FDA Received Date: 11/06/2019
• Supplement Report FDA Received Date: 12/03/2019
• Patient Sequence Number: 1