MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 18IN 5-0 S/A P-3 PRM MP; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	8698G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Were there any adverse patient consequences reported? if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2020 and suture was used.During the procedure, when using the suture to approximate the patient's skin, just as the surgeon was taking the first bite on the patient's skin and was about to pull the suture, the suture falls off from the needle.No information is given regarding patient information and the impacts on the operation.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 1/20/2021.  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: were there any adverse patient consequences reported? since in these 2 weeks there are no confirmation and no other further responses and reports relating to adverse patient consequences, the information is still remained to be unknown, or no adverse patient consequences reported.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.

• Brand Name: PRLNE BLU 18IN 5-0 S/A P-3 PRM MP
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10975497
• Report Number: 2210968-2020-09760
• Device Sequence Number: 11397650
• Product Code: GAW
• UDI-Device Identifier: 10705031019232
• UDI-Public: 10705031019232
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2020

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: 07/31/2024
• Device Model Number: 8698G
• Device Catalogue Number: 8698G
• Device Lot Number: PJQ132
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/16/2020
• Supplement Date Received by Manufacturer: 12/24/2020
• Initial Report FDA Received Date: 12/09/2020
• Supplement Report FDA Received Date: 01/20/2021
• Patient Sequence Number: 1