MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 18IN 3-0 S/A PS-1 PRM MP; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	8663G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).The following information was requested, but unavailable: could you please confirm the quantity of procedures that were affected by "needle breakage"? could you please specify the quantity of devices that presented "needle breakage" during each procedure? were there any patient consequences? name and date of the procedure(s)? are any samples available of evaluation? please provide facility contact person¿s name, mailing address and telephone.A shipper kit will be sent to help return the product to us.I have no more information that what has already been given.I 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 in 2021 and suture was used.During the procedure, it was reported by the distributor that the customer requests product return due to not being satisfied with the product.Needles keep breaking.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 6/16/2021.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.Additional h6 component code: g07002 ¿ conforming device.Additional h3 investigation summary: the product was returned for evaluation.Visual inspection and functional test evaluation were conducted on the returned device.Visual analysis of the returned sample determined that two unopened samples of product code 8663 were received for evaluation.Visual inspection of the unopened samples and no defects were found on the packages.The samples were opened, and the swage and attachment area were noted to be as expected.No needle breakage was observed on body, tip, or swage area.The sutures were dispensed without problems and examined along of the strand and no defects were observed.Also, the samples were tested by resistance test to needle and met the 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.It should be noted that as part of our quality process, each batch is randomly inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.The event described could not be confirmed as the device performed without any defect noted and the actual complaint sample was not received for evaluation.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 05/18/2021.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.Additional information: h6, h4.A manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.

• Brand Name: PRLNE BLU 18IN 3-0 S/A PS-1 PRM MP
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11680131
• Report Number: 2210968-2021-03456
• Device Sequence Number: 3050136
• Product Code: GAW
• UDI-Device Identifier: 10705031018624
• UDI-Public: 10705031018624
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/23/2021

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: 05/31/2025
• Device Model Number: 8663G
• Device Catalogue Number: 8663G
• Device Lot Number: QGBEKS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2021
• Initial Date Received by Manufacturer: 03/23/2021
• Supplement Date Received by Manufacturer: 05/18/2021; 05/25/2021
• Initial Report FDA Received Date: 04/16/2021
• Supplement Report FDA Received Date: 05/18/2021; 06/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1