MAUDE Adverse Event Report: ETHICON INC. ETHILON SUTURE 18"(45CM) 5-0 BLK; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	661G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot mjj550, and no non-conformances were identified.Attempts have been 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.
Event or Problem Description
It was reported that a patient underwent an unknown surgery on (b)(6) 2019 and suture was used.During the procedure, the needle was detached from the suture.There were no adverse consequences to the patient.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Investigation summary: an empty labeled winding former, a detached needle and a dispensed suture were received for evaluation.During the visual inspection of the sample, the closure of the channel needle was noted distorted.The barrel hole was examined under magnification and remnant suture was noted, the suture end is severely cut (damaged), resulting in a clip off defect.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.According to the sample condition and the assignable cause of the performance pull off - suture needle is a clip off defect, this defect is caused by excessive pressure on the suture during swaging of the needle and consequently breaking.

• Brand Name: ETHILON SUTURE 18"(45CM) 5-0 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: 9335899
• Report Number: 2210968-2019-90037
• Device Sequence Number: 1850147
• Product Code: GAR
• UDI-Device Identifier: 10705031007697
• UDI-Public: 10705031007697
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K946173
• 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): 10/30/2019

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: 07/31/2023
• Device Catalogue Number: 661G
• Device Lot Number: MJJ550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2019
• Initial Date Received by Manufacturer: 10/30/2019
• Supplement Date Received by Manufacturer: 11/28/2019
• Initial Report FDA Received Date: 11/18/2019
• Supplement Report FDA Received Date: 12/18/2019
• Patient Sequence Number: 1