MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 27IN 3-0 S/A SH; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J316H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).H6 component code: g07002 - device evaluation pending.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.The device 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.Additional information was requested, and the following was obtained via: -qty to be returned of (b)(4): 1 :2.-qty of product involved of (b)(4): 1 : 2.A manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.D4: full udi currently unavailable since the exact lot of the suspected device cannot be determined.
Event or Problem Description
It was reported that a patient underwent a urological procedure on (b)(6) 2024 and suture was used.During the procedure, it was reported by a sales rep that, during an unknown urological surgery, when used for a case of a robot, the suture was broken a choppy.Lot number - uambpt or ubmsab - unknown if this is the correct lot number.It was not a control release needle.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information: d4 lot: uambpt, udi: (b)(4).D4, lot: ubmsab, udi: (b)(4).H3 evaluation: the product was returned to for evaluation.One empty labeled winding former and one small needle-suture piece were received for analysis.Product code.Additionally, a photo was provided, and with the same condition as the received sample.During the visual inspection of the needle, the swage area was noted with several significant tool marks.The received suture was inspected, and no breakage suture was observed.The was noted to be broken and damaged (crushed and broken part) on the surface suture and near the cut area probably caused by a surgical instrument.Also, body fluids were noted along the strand.As per the returned conditions of the sample, no functional test was performed.The other section of the suture was not returned for analysis.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.According to the information received, it was reported breakage suture.The product was returned to ethicon for evaluation.One empty labeled winding former and one small needle-suture piece were received for analysis.Additionally, a photo was provided, and with the same condition as the received sample.During the visual inspection of the sample, the swage area was noted with several significant tool marks.The needles were noted with the suture to be still attached to the barrel hole.The received suture was inspected, and no breakage suture was observed.Also, body fluids were.As per the returned conditions of the sample, no functional test was performed.The other section of the suture was not returned for analysis.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: VCL CT BRD VIO 27IN 3-0 S/A SH
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 19783868
• Report Number: 2210968-2024-07411
• Device Sequence Number: 15481498
• Product Code: GAM
• UDI-Device Identifier: 10705031038738
• UDI-Public: 10705031038738
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2024

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: J316H
• Device Lot Number: UAMBPT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2024
• Supplement Date Received by Manufacturer: 07/22/2024
• Initial Report FDA Received Date: 07/19/2024
• Supplement Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown