MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 36IN 5-0 D/A V-5; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	8934H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 6/16/2023.H6 component code: g07002.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information was requested, the following was obtained: was there any change in the patient¿s post-operative care due to the prolonged procedure? were there any unexpected outcomes or complications as a result of the prolonged surgery time? what tissue was being sutured when the event occurred? was additional dissection required in other organs/tissues other than the target tissue? please provide the source or name of person providing answers to follow-up questions (not the person relaying/submitting answers to loc or chu).Michelle grijalva with owens & minor for northside forsyth reported the information.No additional information is known or available at this time.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 related reports: 2210968-2023-04376.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2023 and suture was used.During the procedure, the suture was "popping off" needle and not staying in needle swage.Procedure was delayed by ten minutes.New suture needed to be opened to completed procedure.There were no patient consequences.Additional information was requested.

• Brand Name: PRLNE BLU 36IN 5-0 D/A V-5
• 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: 17144048
• Report Number: 2210968-2023-04375
• Device Sequence Number: 1907811
• Product Code: GAW
• UDI-Device Identifier: 10705031022058
• UDI-Public: 10705031022058
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/16/2023

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: 8934H
• Device Catalogue Number: 8934H
• Device Lot Number: SABBKX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2023
• Initial Report FDA Received Date: 06/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2022
• 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