MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 8"(20CM) 3-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	8534H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device batch mpr938, 8534w19 and no non-conformances were identified.Attempts are being 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.Additional information was requested and the following was obtained: confirm the specific number of devices (total qty actually involved with reported issue) that failed during this one reported event /procedure /one patient? qty impacted: 18 sutures.Event occurred on one patient during the same procedure.Note: events reported via medwatch 2210968-2019-86044, 2210968-2019-86045, 2210968-2019-86046, 2210968-2019-86047, 2210968-2019-86048, 2210968-2019-86049, 2210968-2019-86050, 2210968-2019-86051, 2210968-2019-86052, 2210968-2019-86053, 2210968-2019-86055, 2210968-2019-86056, 2210968-2019-86057, 2210968-2019-86058, 2210968-2019-86059, 2210968-2019-86060, 2210968-2019-86061, 2210968-2019-86062.
Event or Problem Description
It was reported that the patient underwent an unknown procedure on an unknown date and suture was used.During the procedure, the suture was snapping off the needle while in use.There were no delays to the procedure.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 09/18/2019.Additional information was requested and the following was obtained: did all 18 devices reported all had issue of suture pulling off /separation from needle during same patient/same procedure? if yes,confirm when reported issue noticed for all 18 devices.It was confirmed during use on same patient and same procedure while suturing and handling, cannot provide how many occurred during suturing and how many during just handling.Additional h3: it was reported performance pull off suture needle.Two opened boxes with unopened samples of product code 8534, lot # mpr938 were returned for analysis.During the visual inspection of the samples, no defects were found on the packages.The samples were opened, and 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 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 conditions of the sample received, no performance pull off suture needle was found, and the tested sample met the finished goods requirements.Event occurred on one patient during the same procedure.Representative samples returned to support investigation of 18 device issues captured in reports 2210968-2019-86044, 2210968-2019-86045, 2210968-2019-86046, 2210968-2019-86047, 2210968-2019-86048, 2210968-2019-86049, 2210968-2019-86050, 2210968-2019-86051, 2210968-2019-86052, 2210968-2019-86053, 2210968-2019-86055, 2210968-2019-86056, 2210968-2019-86057, 2210968-2019-86058, 2210968-2019-86059, 2210968-2019-86060, 2210968-2019-86061, 2210968-2019-86062.Analysis results have been included in follow-up reports for each.

• Brand Name: PROLENE SUTURE 8"(20CM) 3-0 BLU
• 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: 8925556
• Report Number: 2210968-2019-86062
• Device Sequence Number: 16656167
• Product Code: GAW
• UDI-Device Identifier: 10705031016774
• UDI-Public: 10705031016774
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K133356
• 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): 07/29/2019

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: 11/30/2023
• Device Catalogue Number: 8534H
• Device Lot Number: MPR938
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2019
• Initial Date Received by Manufacturer: 07/29/2019
• Supplement Date Received by Manufacturer: 08/26/2019
• Initial Report FDA Received Date: 08/23/2019
• Supplement Report FDA Received Date: 09/18/2019
• Patient Sequence Number: 1