MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 18IN 6-0 S/A P-3 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J492G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.(b)(4).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.Additional information was requested and the following was obtained: this item was return to us by our customer the only information i have is the note of needle separation from thread.The following information was requested, but unavailable: what was the name of the procedure? what was the procedure date? unknown.When was the needle detached/pulled off from the suture (in the package, during removal from package, during handling or during use on the patient)? please specify unknown what was used to complete the procedure? unknown.Was there any adverse consequence associated with the patient? unknown.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.The needle was separating form the thread.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # = > pc-(b)(4).Date sent to the fda: 09/14/2021 h6 component code: g07002 no device problem found.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.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, or its employees that the report constitutes an admission that the product, ethicon, 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.H3 investigation summary: an opened box with nine packets of product code j492 was returned for analysis with the packaging closed.Upon initial inspection, of the samples, no external damages were observed on the packets.In order to evaluate the conditions of the returned samples, the packets were opened, and no defects were detected.The swage and attachment area was noted to be as expected.The sutures were dispensed without problems and examined along the strand to detect any issue on the suture and no defects were observed during evaluation.Functional test was performed, and the pull force result were above the minimum requirements.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.As part of quality process, all devices are manufactured, inspected, and released to approved specifications.There may have been other circumstances or issues that occurred during the use of the device that we were unable to duplicate during our laboratory analysis.

• Brand Name: VCL CT BRD UD 18IN 6-0 S/A P-3 PRM MP
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12313854
• Report Number: 2210968-2021-07276
• Device Sequence Number: 19628508
• Product Code: GAM
• UDI-Device Identifier: 10705031040465
• UDI-Public: 10705031040465
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2021

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: 07/31/2025
• Device Model Number: J492G
• Device Catalogue Number: J492G
• Device Lot Number: QJMUMU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2021
• Initial Date Received by Manufacturer: 07/16/2021
• Supplement Date Received by Manufacturer: 08/23/2021
• Initial Report FDA Received Date: 08/12/2021
• Supplement Report FDA Received Date: 09/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1