MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 36IN 3-0 S/A CT-1; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J344H
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.What was the initial procedure? in event description indicate that suture broke 10 times, could you please confirm with how many products occurred this issue? please clarify: did the suture break or did the suture detach from the needle? 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 procedure on an unknown date; and a suture was used.During the procedure, the suture broke at the junction with the needle.Another like device was used to complete the procedure.There were no adverse patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 06/09/2020.Additional information: h6.A manufacturing record evaluation was performed for the finished device kpz116 batch number, and no non-conformances were identified.Additional information was requested and the following was obtained: 1.What was the initial procedure? unknown.2.In event description indicate that suture broke 10 times, could you please confirm with how many products occurred this issue? no, that description means the suture had been sutured 10 times after, this suture was broken.3.Will the product be returned for investigation? yes.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 7/28/2020.Device code: 1562.Investigation summary: it was reported performance breakage suture.An empty opened foil, a labeled winding former, a dispensed suture and a detached needle of product code j344, lot # kpz116 were received for evaluation.During the visual inspection of the sample, the swage and attachment area of detached needle were noted to be as expected.The barrel hole was examined under 20x 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 breakage suture is a clip off defect, this defect is caused by excessive pressure on the suture during swaging of the needle and consequently breaking and due to this condition.

• Brand Name: VCL CT BRD VIO 36IN 3-0 S/A CT-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10105783
• Report Number: 2210968-2020-04280
• Device Sequence Number: 16352568
• Product Code: GAM
• UDI-Device Identifier: 10705031039070
• UDI-Public: 10705031039070
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/23/2020

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: 11/30/2021
• Device Model Number: J344H
• Device Catalogue Number: J344H
• Device Lot Number: KPZ116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2020
• Initial Date Received by Manufacturer: 05/23/2020
• Supplement Date Received by Manufacturer: 06/02/2020; 07/24/2020
• Initial Report FDA Received Date: 06/01/2020
• Supplement Report FDA Received Date: 06/09/2020; 07/28/2020
• Patient Sequence Number: 1