MAUDE Adverse Event Report: ETHICON INC. PDS+ VIO 27IN 3-0 S/A SH; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	PDP316H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).Additional information: h6 component code: g07002 - device not returned additional information provided: was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: --> unknown, is the patient part of a clinical study --> unknown, additional information has been requested however not received.Attempts to obtain the device have been made.If further details are received at a later date a supplemental medwatch will be sent.Please provide clarification on the quantity of pieces affected specifically in relation to the issue with the needle? - did the needle fall into the patient? if yes, ¿ was the needle piece(s) retrieved during the same procedure? ¿ were x-rays taken to locate the needle piece(s)? ¿ what measures were taken to retrieve the broken piece? ¿ was there any additional tissue damage as a result of searching for the needle piece? - please perform and document the follow up attempt for product return.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.
Event or Problem Description
It was reported a patient underwent a laparoscopic cholecystectomy on 11-jan-2024 and suture was used.The needle broke at the swage intra op.There were no patient consequences.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 3/1/2024.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.H6 component code: g07002 no device problem found.A review of the batch manufacturing records was conducted, and no related non-conformances were identified.A device has been received, however clarification is requested whether the product belongs to this complaint.The following information was requested: product code: pdp316.Lot : tambse.1.Please clarify if the additional device belong to this complaint? if so, what is the product code and lot number of the unknown returned product? 2.If not, could you please clarify if the additional received product belongs to a different complaint? if so, can you please provide the complaint number.3.If the device was not reported before, please provide more details of device malfunction.4.If the product doesn¿t belong to any complaint and was returned in error, please let us know so we can discard it or advise if the product is required to be returned.5.If you have the correct complaint product in your possession, please forward the product to ethicon as soon as possible.If you have already sent the product to ethicon, please reply to (b)(6) with the ups, dhl or fedex tracker number.H3 investigational summary: the product was returned to ethicon for evaluation.Visual inspection was conducted on the returned device.The returned sample revealed that it was received ninty-three unopened samples that pertain to product code pdp316h.As per the sampling plan, a visual inspection was performed on thirty-two unopened samples.The swage and attachment area were noted as expected.The tip and body of the needle were examined under magnification and no anomalies or issues related to needle breakage were found.In addition, the samples were tested by resistance test to needle and met the requirements.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as the device performed without any difficulties noted.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 3/26/2024 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.Additional information was requested, the following was obtained: 1.Please clarify if the additional device belong to this complaint? if so, what is the product code and lot number of the unknown returned product? nicole: ot informed that the suture belonged to tambsd.2.If not, could you please clarify if the additional received product belongs to a different complaint? if so, can you please provide the complaint number.Nicole: ot informed that the suture belonged to tambsd.3.If the device was not reported before, please provide more details of device malfunction.Nicole: ot only informed me of this incident.4.If the product doesn¿t belong to any complaint and was returned in error, please let us know so we can discard it or advise if the product is required to be returned.Nicole: ot informed that the suture belonged to tambsd.5.If you have the correct complaint product in your possession, please forward the product to ethicon as soon as possible.If you have already sent the product to ethicon, please reply to ethwcqcom@its.Jnj.Com with the ups, dhl or fedex tracker number.

• Brand Name: PDS+ VIO 27IN 3-0 S/A SH
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC. JUAREZ; avenida de las torres 7125,; col salvacar; ciudad juarez 32604 ; MX 32604
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18654909
• Report Number: 2210968-2024-01015
• Device Sequence Number: 8276312
• Product Code: NEW
• UDI-Device Identifier: 10705031048027
• UDI-Public: 10705031048027
• Combination Product (Y/N): Y
• Initial Reporter Country: SN
• PMA/510(K) Number: K061037
• 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,Followup
• Report Date (Section B): 03/26/2024

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 Expiration Date: 12/31/2024
• Device Catalogue Number: PDP316H
• Device Lot Number: TAMBSD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2024
• Supplement Date Received by Manufacturer: 02/08/2024; 03/12/2024
• Initial Report FDA Received Date: 02/06/2024
• Supplement Report FDA Received Date: 03/01/2024; 03/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2023
• 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