MAUDE Adverse Event Report: ETHICON INC. PROLENE BLU 30IN 3-0 D/A SH; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	8528H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint: (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 additional information was requested, and the following was obtained: what do you mean by, "the sutures which break at a low tension threshold?" do you mean the sutures broke during the procedure? yes, the sutures broke without exerting excessive tension.Did 6 wires break during this single patient's procedure? yes, on (b)(6) 2020, during the installation of a heartware.Events submitted via 2210968-2020-08191, 2210968-2020-08192, 2210968-2020-08193, 2210968-2020-08194, and 2210968-2020-08196.
Event or Problem Description
It was reported that the patient underwent a cardiac surgery on (b)(6) 2020, and the suture was used.During installation of heart ware, a fragility of suture, which break at a low tension threshold was noted.The suture broke without exerting excessive tension.Another like suture box from the same batch was opened to finish the procedure without problem.There were no clinical consequences reported.

• Brand Name: PROLENE BLU 30IN 3-0 D/A SH
• 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: 10717225
• Report Number: 2210968-2020-08195
• Device Sequence Number: 3060849
• Product Code: GAW
• UDI-Device Identifier: 10705031091108
• UDI-Public: 10705031091108
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2020

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: 01/31/2025
• Device Model Number: 8528H
• Device Catalogue Number: 8528H
• Device Lot Number: QBBEHD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Initial Date Received by Manufacturer: 09/29/2020
• Supplement Date Received by Manufacturer: 10/26/2020
• Initial Report FDA Received Date: 10/22/2020
• Supplement Report FDA Received Date: 11/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1