MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 2X24IN 8-0 D/A BV175-6 EP; SUTURE, NONABSORBABLE, SYNTHETIC

Model Number	EPM8743
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (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.Investigation summary : one picture was received for evaluation.Upon visual inspection an empty folder and two detached needles code epm8743 were observed.No conclusion could be reached as to what caused the reported complaint.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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 that a patient underwent a procardiac procedure on an unknown date and suture was used.The user experienced the problem of the suture needle pull off, during the procedure.They changed to another one to complete the surgery.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 9/22/2021.H6 component code: g07002 - no device problem found.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, 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, h3,d9.H3 investigation summary: photo analysis: one picture was received for evaluation.Upon visual inspection an empty folder and two detached needles code epm8743were observed.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.No conclusion could be reached as to what caused the reported complaint since the sample was not returned for analysis.As part of quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.,1 empty folder piece and a sealed packet.Device analysis: an empty opened folder and one packet of product code epm8743 were returned for analysis with the packaging closed.Upon initial inspection of the samples, no external damages were observed on the packet.In order to evaluate the conditions of the returned sample, the packet was opened, and no defects were detected.The swage and attachment area were 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.The product code is multistrand and each folder contains two strands double armed.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: PRLNE BLU 2X24IN 8-0 D/A BV175-6 EP
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12353051
• Report Number: 2210968-2021-07584
• Device Sequence Number: 14331561
• Product Code: GAW
• UDI-Device Identifier: 10705031206748
• UDI-Public: 10705031206748
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2021

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: 03/31/2025
• Device Model Number: EPM8743
• Device Catalogue Number: EPM8743
• Device Lot Number: QDBEPA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2021
• Initial Date Received by Manufacturer: 08/01/2021
• Supplement Date Received by Manufacturer: 08/27/2021
• Initial Report FDA Received Date: 08/23/2021
• Supplement Report FDA Received Date: 09/22/2021
• Patient Sequence Number: 1