MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 36IN 2-0 D/A RB-1; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	8559H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 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 was requested, and the following was obtained via: "please clarify, was the suture broken and the needle separated from the suture during the procedure? yes.Was the suture broken or frayed during the procedure? no.Did the event occur during one or multiple patient procedures? one procedure.What is the total number of procedures? one.If this event occurred in multiple procedures, please create a product complaint for each event and provide the respective reference number(s).Sample analysis: the product was returned for evaluation.Visual inspection was conducted on the returned sample.Visual analysis of the returned sample determined that an empty labeled winding former and a needle-suture of product code 8559h were received for evaluation.An incorrect swage was noted since the marks of the swage area was misaligned (one stake near the suture) and consequently, the suture is severely cut.Based on the information currently available, the incorrect swage was identified during the investigation of the sample received.This product issue will be addressed through ethicon quality system.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.
Event or Problem Description
It was reported that a patient underwent a hemorrhoidectomy procedure on (b)(6) 2022 and suture was used.During the procedure, the suture was torn when the purse-string suture was performed.The device was used on the rectum.Another like device was used to complete the case.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: PRLNE BLU 36IN 2-0 D/A RB-1
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo PR ; *
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 14720134
• Report Number: 2210968-2022-04625
• Device Sequence Number: 4909039
• Product Code: GAW
• UDI-Device Identifier: 10705031017122
• UDI-Public: 10705031017122
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/16/2022

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 Expiration Date: 10/31/2023
• Device Model Number: 8559H
• Device Catalogue Number: 8559H
• Device Lot Number: MMH523
• 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: 06/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2018
• 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