MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 48"(122CM) 2-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	D9694
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.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.It was reported:" the surgeon had to remove all of the sutures and start over" please clarify: what tissue was being approximated or sutured when it broke? was there any change in the patient¿s post-operative care due to the "removing sutures and start over" procedure? was reoperation necessary to remove the suture and re-close the wound? "the procedure was completed suture from a different lot with no patient consequence." was this surgery completed with another/new suture product? explain.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.
Event or Problem Description
It was reported that a patient underwent a thoracic procedure on (b)(6) 2020 and suture was used.During the procedure, the suture broke.The surgeon had to remove all of the sutures and start over.The procedure was completed with suture from a different lot with no patient consequence.Additional information was requested.

• Brand Name: PROLENE SUTURE 48"(122CM) 2-0 BLU
• 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: 10690452
• Report Number: 2210968-2020-08074
• Device Sequence Number: 2836551
• Product Code: GAW
• UDI-Device Identifier: 10705031034266
• UDI-Public: 10705031034266
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/06/2020

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: 02/28/2022
• Device Model Number: D9694
• Device Catalogue Number: D9694
• Device Lot Number: LC6703
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2020
• Initial Report FDA Received Date: 10/16/2020
• Patient Sequence Number: 1