MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 4X30IN 7-0 D/A BV175-6 MP; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	M8731
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.Could you please confirm if the issue occurred with the suture or with the needle? device return follow up.
Event or Problem Description
It was reported that a patient underwent a thoracotomy on (b)(6) 2020 and suture was used.During the procedure, the device kept breaking.Switched to another lot to complete the case.There were no adverse patient consequences reported.Additional information has been requested.
Additional Manufacturer Narrative
(b)(4) date sent to the fda: 7/7/2020 additional information: d4, h4, h6 a manufacturing record evaluation was performed for the finished device batch pkb748, m873119 and no non-conformances were identified.

• Brand Name: PRLNE BLU 4X30IN 7-0 D/A BV175-6 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: 10086569
• Report Number: 2210968-2020-04098
• Device Sequence Number: 16742332
• Product Code: GAW
• UDI-Device Identifier: 10705031045958
• UDI-Public: 10705031045958
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 05/13/2020

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: 08/31/2024
• Device Model Number: M8731
• Device Catalogue Number: M8731
• Device Lot Number: PKB748
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/13/2020
• Supplement Date Received by Manufacturer: 06/29/2020
• Initial Report FDA Received Date: 05/26/2020
• Supplement Report FDA Received Date: 07/07/2020
• Patient Sequence Number: 1