MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 4X30IN 7-0 D/A BV175-8 EP; SUTURE, NONABSORBABLE, SYNTHETIC

Model Number	EPM8751
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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.(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information was requested and the following was obtained: please provide the lot number: device return status: lot number: scebeax.I have the suture to return, it is all sterile unopened- if you provide shipping address and/or label i can send out asap, i have in my possession as the account sequestered this lot number due to breakage.Evaluation: the product was returned for evaluation.Visual inspection and functional test evaluation were conducted on the returned device.Packets and one empty opened overwrap of product were returned for analysis with the packaging closed.Upon initial inspection, of the samples, no external damages were observed on the packet.A visual inspection was performed on samples, and no defects were found on the packages.The samples were opened, and the swage and attachment area was noted to be as expected.The sutures were dispensed without problems and examined along the strand and no defects, damage, or suture breakage were noted.A functional test was performed using and the tensile strength force was above the minimum requirement.The device performed without any defect noted.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.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Associated events submitted via mw# 2210968-2022-04547, mw# 2210968-2022-04548, mw# 2210968-2022-04550.
Event or Problem Description
It was reported that a patient underwent an open heart procedure on an unknown date in 2022 and the suture was used.During surgery, the suture broke.The procedure was completed successfully with no patient harm.There were no adverse patient consequences reported.Additional information was requested.

• Brand Name: PRLNE BLU 4X30IN 7-0 D/A BV175-8 EP
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183; km. 8.3; san lorenzo 00754 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 14691338
• Report Number: 2210968-2022-04549
• Device Sequence Number: 12456950
• Product Code: GAW
• UDI-Device Identifier: 10705031206861
• UDI-Public: 10705031206861
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/14/2022

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 Model Number: EPM8751
• Device Catalogue Number: EPM8751
• Device Lot Number: SCBEAX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2022
• Initial Report FDA Received Date: 06/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown