MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 30IN 4-0 D/A SH-1; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	8526H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Component code: g07002 - device not returned.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.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.Additional information was requested, and the following was obtained via: 1.Please provide the lot number.Ans: not available.2.Was there any adverse consequence associated with the patient? ans: no adverse consequences was noted.
Event or Problem Description
It was reported that a patient underwent a mitral valve replacement procedure on (b)(6) 2023 and suture were used.During the procedure, the suture detached from needle intra-op.Needle was found and discarded.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4) date sent to the fda: 4/18/2023 additional information: d4, h4, h6 a manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.The following additional information was received: i took note from ecm there is an update to the product investigation for (b)(4) where the physical product analysis is added.However, i would like to highlight as per my email below, the 8526h sample is actually not for this complaint (b)(4) - the correct pc# for the sample is (b)(4).As such, may i request your end to amend the pi accordingly? - (b)(4) ((b)(6)): as per note a-8915596, the sample is not for this pc#.Hence, kindly remove the product return analysis from the product investigation.- (b)(4) ((b)(4)): as per note a-8915541, the sample is for this pc#.Hence, kindly add the product return analysis (as above) to (b)(4).Please let me know if you require further clarification on the above.Many thanks and apologies for the inconvenience caused.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.Product complaint # (b)(4) date sent to the fda: 4/18/2023 corrected information: g1 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.

• Brand Name: PRLNE BLU 30IN 4-0 D/A SH-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 ; 9083863534
• MDR Report Key: 16625191
• Report Number: 2210968-2023-02129
• Device Sequence Number: 5324219
• Product Code: GAW
• UDI-Device Identifier: 10705031016644
• UDI-Public: 10705031016644
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/18/2023

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: 8526H
• Device Catalogue Number: 8526H
• Device Lot Number: SDBHXB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2023
• Supplement Date Received by Manufacturer: 03/28/2023; 05/30/2023; 06/07/2023
• Initial Report FDA Received Date: 03/27/2023
• Supplement Report FDA Received Date: 04/18/2023; 05/30/2023; 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2022
• 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