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.Additional h3 investigation summary: it was received for analysis a needle-suture piece of product code osm8738, lot kmj392.During the visual inspection of the needle-suture, the swage and attachment area were noted to be as expected.However, marks the end of the suture pieces cut that appears to be by the use of a surgical instrument could be observed.Additionally, the functional test was performed on a suture piece and the tensile strength force was above the minimum requirement.As with any device, care should be taken to avoid damage to the strand when handling.Avoid the crushing or crimping action of the surgical instruments, such as needle holders and forceps.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Due to condition of the opened sample, the assignable cause of performance breakage suture suggests an improper handling.

• 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: 9978351
• Report Number: 2210968-2020-03215
• Device Sequence Number: 3374867
• 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): 03/27/2020

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2020
• Initial Date Received by Manufacturer: 03/27/2020
• 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