MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 18IN 3-0 S/A PS-2 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J497H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.During an unknown procedure, there was an issue of the needle coming off the suture, there were at least a dozen where the needle popped off while suturing.There was no patient consequence was reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).H6 component code: g07002 - device not returned.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Additional information was requested, the following was obtained: additional information was requested, the following was obtained: the new information indicates the event happened on 4 different occasions.Please clarify how many sutures pulled off the needle during each procedure as 12 pull off sutures were reported: procedure 1: 2 suture procedure 2: 3 suture procedure 3: 4 suture procedure 4: 3 suture additional information was requested, the following was obtained: what is the account name? please specify the total number of needles that popped off while suturing.Please clarify, were the needles breaking? or were the needles detaching from the suture thread? did all the faulty sutures share the same lot number (tcbbdha0)? if no, please provide corresponding lot number for each damaged suture.Did the reported issue occur over the same patient procedure? if no, please clarify the total amount of patient events.Are the damaged products available to be returned for evaluation? if yes, please clarify how many will be returned and to who and where can a return kit be send for recollection? please clarify how many products need to be replaced and provide replacement contact and full address.Account name ¿ green bay surgical center at least 12 needles popped off while sewing no, needles did not break.The suture detached right at the needle.Yes, all needle came from the same lot number this event happened on 4 different occasions.No, the suture is not available for return how many to be replaced, 12 suture contact ¿(b)(6) 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.

• Brand Name: VCL CT BRD UD 18IN 3-0 S/A PS-2 PRM MP
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-GMBH; robert-koch strasse 1; p.o. box 1409; norderstedt ; GM
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 20146535
• Report Number: 2210968-2024-09293
• Device Sequence Number: 8397425
• Product Code: GAM
• UDI-Device Identifier: 10705031040632
• UDI-Public: (01)10705031040632(11)230302(17)280831(10)TCBBDHA0
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/05/2024

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: J497H
• Device Lot Number: TCBBDHA0
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2024
• Initial Report FDA Received Date: 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/02/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown