MAUDE Adverse Event Report: ETHICON INC. PRLNE O/SZ BLU 2X18IN 8-0 D/A BV130-5 MP; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	OSM8738
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Additional information was requested, and the following was obtained: what was used to complete the procedure? =>no further information is available.Was the surgery completed successfully? =>no further information is available.Was the surgery delayed due to the issue? =>no further information is available.If yes how many minutes? was there any alleged deficiency noted with the suture during the surgery? please explain =>no further information is available.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.
Event or Problem Description
It was reported that a patient underwent a coronary artery bypass surgery on an unknown date; and a suture was used.During the procedure, the suture broke during vascular anastomosis.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 06/01/2020.A manufacturing record evaluation was performed for the finished device lot kmj392, and no non-conformances were identified.

• Brand Name: PRLNE O/SZ BLU 2X18IN 8-0 D/A BV130-5 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: 9978357
• Report Number: 2210968-2020-03218
• Device Sequence Number: 16987906
• Product Code: GAW
• UDI-Device Identifier: 10705031231252
• UDI-Public: 10705031231252
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133356
• 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): 03/26/2020

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: 10/31/2021
• Device Model Number: OSM8738
• Device Catalogue Number: OSM8738
• Device Lot Number: KMJ392
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/26/2020
• Supplement Date Received by Manufacturer: 05/29/2020
• Initial Report FDA Received Date: 04/20/2020
• Supplement Report FDA Received Date: 06/01/2020
• Patient Sequence Number: 1