MAUDE Adverse Event Report: ETHICON INC. ETHILON SUTURE 30"(75CM) 3-0 BLK; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	1673H
Medical Device Problem Code	Break (1069)
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 kdj814 and no non-conformances were identified.Device evaluation summary: the actual device was received for evaluation.One empty labeled winding former and a dispensed suture of product code 1673, lot kdj814 were received for analysis.During visual inspection of the sample, a end of the suture was observed cut appears to be by use of surgical instrument.No other defects were found along of strand.In addition the needle was not returned for evaluation.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.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.According to the sample condition it was suggest an improper handling of the sample.
Event or Problem Description
It was reported that a patient underwent a foot procedure in 2019 and suture was used.The suture kept snapping.A similar device was used to complete the case.No patient consequences were reported.

• Brand Name: ETHILON SUTURE 30"(75CM) 3-0 BLK
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9460965
• Report Number: 2210968-2019-90839
• Device Sequence Number: 3090952
• Product Code: GAR
• UDI-Device Identifier: 10705031001923
• UDI-Public: 10705031001923
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/21/2019

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: 03/31/2021
• Device Catalogue Number: 1673H
• Device Lot Number: KDJ814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/21/2019
• Initial Report FDA Received Date: 12/12/2019
• Patient Sequence Number: 1