MAUDE Adverse Event Report: ETHICON INC. PROLENE BLU 18IN 6-0 S/A P-3 PRM MP; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	8695H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (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.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.The single complaint was reported with multiple events.There are no additional details regarding the additional patient events.Additional information was requested, and the following was obtained via:.Did the event occur intra-op or post-op? post-op.What is the name of the procedure n/a.Provide the name of the hospital medsyn im not possible to obtain further information ! - was there any adverse consequence associated with the patient? no - please provide the lot number: he don¿t have - what is the total number of products involved in this event? one - what is the total number of procedures? he don¿t now - have any of these events been previously reported to ethicon? if so, provide the respective reference number(s).No - if this event occurred in multiple procedures, please create a product complaint for each event and provide the respective reference number(s).If it is not possible to obtain further details or no additional information is available, please state that in your response.Unfortunately, i cannot get any more information about this case.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.Post-op, it was reported that that the sales rep has received a message from a person that used to be a nurse but now works as a sales rep.A patient comes to take stitches.The thread had split in several places and left gaps on the suture line.And the threads breaks even more when he tried to take away the last part of the suture.It have had happened earlier on several patients but different times.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: PROLENE BLU 18IN 6-0 S/A P-3 PRM MP
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.; 1000 route 202; raritan 08869
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16704523
• Report Number: 2210968-2023-02540
• Device Sequence Number: 20238171
• Product Code: GAW
• UDI-Device Identifier: 10705031091443
• UDI-Public: 10705031091443
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/07/2023

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: 8695H
• Device Catalogue Number: 8695H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2023
• Initial Report FDA Received Date: 04/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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