MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 24IN 6-0 D/A CC175-8 MP; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	1966G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Additional information was requested, and the following was obtained: how many devices that had suture needle pull off or detached issue? 3 foils.How many devices that had needle breakage? 1 foils.How many devices that had suture breakage? 2 foils.For the device in which "the needle gave away".Did the needle pull off/detached from the suture during use? or did the needle broke? ans: the needle broke during the surgery while suturing, also the suture got detached from the needle inone sample and in the other the suture gave away.Were there any patient consequences? there was no patient consequence.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformance were identified.Events reported via: 2210968-2021.
Event or Problem Description
It was reported that a patient underwent a fistula procedure on (b)(6) 2021 and suture was used.During the procedure, when the surgeon started to close fistula the suture got detached from the needle.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # = > (b)(4) date sent to the fda: 11/17/2021 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: d9, h3, h6 additional h3 investigation summary: h3 investigation summary: one labeled winding former with a needle/suture product code w8807 were returned for analysis.The product code is double armed.Upon visual analysis of the returned sample revealed that, the extreme suture was noted to be severely cut and the needle was not received for evaluation.As per returned conditions of the sample no functional test was performed.The clip off defect observed during the visual assessment has been correlated to the manufacturing process.This defect is caused by excessive pressure on the suture during swaging of the needle and consequently breaking.Based on the information currently available, the clip off was identified during the investigation of the sample received.This product issue will be addressed through quality system.Date sent to the fda: 11/17/2021 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.Corrective data: d1, d2b, d4, d2a, h4 product code and lot number a manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.

• Brand Name: PRLNE BLU 24IN 6-0 D/A CC175-8 MP
• 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: 12368782
• Report Number: 2210968-2021-07711
• Device Sequence Number: 3848437
• Product Code: GAW
• UDI-Device Identifier: 10705031003187
• UDI-Public: 10705031003187
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2021
• 2 Devices were Involved in the Event: 1 2

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: 08/31/2024
• Device Model Number: 1966G
• Device Catalogue Number: W8807
• Device Lot Number: PKH899
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2021
• Supplement Date Received by Manufacturer: 11/04/2021
• Initial Report FDA Received Date: 08/25/2021
• Supplement Report FDA Received Date: 11/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2019
• 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