MAUDE Adverse Event Report: ETHICON INC. ETHILON SUTURE 30IN(75CM) 5-0 BLK; SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE

Catalog Number	F2413H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.
Event or Problem Description
It was reported that the patient underwent dental surgery on (b)(6) 2019 and suture was used.During the procedure the needle pulled off from the thread.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional evaluation summary: representative samples were returned for evaluation.During the visual inspection of the 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.Per the conditions of the samples received, no performance pull off suture needle were found, and the tested samples met the finished goods requirements.An empty opened overwrap, a labeled winding former with a undispensed suture piece, a dispensed suture piece and a detached needle of product code f2413, lot mkr824 were received for analysis.During the visual inspection of sample, the swage and attachment area were not as expected; since, present a mark in the half the second hit of stakes were noted, causing that the suture was severely cut (damaged) and consequently it was detached from the needle.The sutures pieces were examined along of strands and the ends were damaged.Per the condition of the sample received, the assignable cause of the performance - pull off suture needle suggest is an incorrect swage defect.The actual device batch number associated with this event is not known.The international affiliate reports the following possible batch numbers: batch mkr824; date of mfg - 9/5/2018 ; exp.Date - 8/31/2023.Batch meq877 ; date of mfg.: 05/31/2018; expiration date: 04/30/2023.A review of the manufacturing record was performed for the possible finished device batch lots and no non-conformances were identified.

• Brand Name: ETHILON SUTURE 30IN(75CM) 5-0 BLK
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8470712
• Report Number: 2210968-2019-79858
• Device Sequence Number: 13847085
• Product Code: GAR
• UDI-Device Identifier: 10705031238916
• UDI-Public: 10705031238916
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2019

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: F2413H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2019
• Initial Date Received by Manufacturer: 03/05/2019
• Supplement Date Received by Manufacturer: 03/05/2019
• Initial Report FDA Received Date: 04/01/2019
• Supplement Report FDA Received Date: 04/30/2019
• Patient Sequence Number: 1