MAUDE Adverse Event Report: ETHICON INC. PROLENE SUT 30IN(75CM) 6-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	8776H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot number pbr375, and no non-conformances were identified.Device evaluation summary: thirty-nine unopened samples of product code 8776, lot pbr375 were received for analysis.The complaint sample was not returned for evaluation.During the visual inspection of thirteen samples, no defects were found on the packages.The samples were opened, and the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along of the strands and no defects 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 samples, no performance pull off suture needle was found, and the tested samples met the finished goods requirements.The single complaint was reported with multiple events.There are no additional details regarding the additional events.The following information was requested, but unavailable: please confirm the specific number of patient events.Have any of these events been previously reported to ethicon? if yes, please provide complaint file number.If not, for each patient event please provide additional complaint details: event date, product code and lot number involved, procedure, event description, qty involved? was there any adverse patient outcome? if yes, was there any medical or surgical intervention performed, was procedure completed successfully and how? any sample return.Etc?.
Event or Problem Description
It was reported that a patient underwent an unknown procedure in 2019 and suture was used.The needle is popping off of the suture.There were no patient consequences reported.

• Brand Name: PROLENE SUT 30IN(75CM) 6-0 BLU
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9187425
• Report Number: 2210968-2019-88627
• Device Sequence Number: 11395025
• Product Code: GAW
• UDI-Device Identifier: 10705031020481
• UDI-Public: 10705031020481
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/17/2019

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: 01/31/2024
• Device Catalogue Number: 8776H
• Device Lot Number: PBR375
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/17/2019
• Initial Report FDA Received Date: 10/14/2019
• Patient Sequence Number: 1