MAUDE Adverse Event Report: ETHICON INC. EB EXC 5GRN/5WHT 30IN 2-0 DA V-4 10PLGT; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	PXX22
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.The product upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form the single complaint was reported with multiple devices.There are no additional details regarding the additional devices.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.Did the whole needle detach/separate/pull off from the whole suture thread? was this noticed before use on patient or during use on patient ? was a total qty of (b)(4) involved in this event report/same procedure? if yes, confirm how many total devices involved with reported issue during use on patient? confirm how many total devices involved with reported issue before use on patient?.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.The suture kept popping off of the suture.It is unknown where the suture was popping off.The procedure was completed with an alternate like device with no patient consequences reported.
Additional Manufacturer Narrative
(b)(4).An empty opened msda folder, four needle-suture combinations inside a msda folder and nine unopened samples of product code pxx22, lot mgm591 were returned for analysis.This product code is multi-strands double armed and required 5 green strands and 5 white strands.During visual inspection of opened sample with four needle-suture combination, 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 or damaged were found.A functional test was performed and the pull force were above the minimum requirements.Nine unopened samples were visually inspected, no defects were found on the packages.Samples were opened and contains ten strands; the swage and attachment area of thirteen needle-suture combinations were noted to be as expected.The sutures were dispensed without problems and examined along of the strand and no defects or damaged were found.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 conditions of the samples, no pull off suture needle were found, and the tested samples met the requirements.

• Brand Name: EB EXC 5GRN/5WHT 30IN 2-0 DA V-4 10PLGT
• 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: 8370495
• Report Number: 2210968-2019-79074
• Device Sequence Number: 11095942
• Product Code: GAT
• UDI-Device Identifier: 10705031049291
• UDI-Public: 10705031049291
• 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): 01/30/2019

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: 05/31/2023
• Device Catalogue Number: PXX22
• Device Lot Number: MGM591
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2019
• Initial Date Received by Manufacturer: 01/30/2019
• Supplement Date Received by Manufacturer: 03/04/2019
• Initial Report FDA Received Date: 02/26/2019
• Supplement Report FDA Received Date: 03/21/2019
• Patient Sequence Number: 1