MAUDE Adverse Event Report: ETHICON INC. PRONOVA SUTURE 24"(60CM) 8-0 BLU; SUTURE, NON ABSORBABLE, SYNTHETIC

Model Number	M3767
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
(b)(4).Note: events reported in 2210968-2021-00715, 2210968-2021-00717.Additional information was requested and the following was obtained: what was used to complete the procedure? no further information is available.Did the surgery was completed successfully? no further information is available.What is the event day and procedure date? no further information is available.What is the lot number? =>no further information is available.No further information will be provided.To date, the device has not been returned.If the device or further details are received, a supplemental medwatch will be received.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 an unknown date and suture was used.During the procedure, three sutures broke.There were no adverse patient consequences reported.No additional information was provided.

• Brand Name: PRONOVA SUTURE 24"(60CM) 8-0 BLU
• Common Device Name: SUTURE, NON ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 11233847
• Report Number: 2210968-2021-00716
• Device Sequence Number: 17178707
• Product Code: GAW
• UDI-Device Identifier: 10705031045255
• UDI-Public: 10705031045255
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K001625
• 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
• Report Date (Section B): 01/08/2021

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: M3767
• Device Catalogue Number: M3767
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/08/2021
• Initial Report FDA Received Date: 01/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1