MAUDE Adverse Event Report: ETHICON INC. PRLNE HS BLU 36IN 3-0 D/A RB-1; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	9556H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts are being 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 the patient underwent a coronary artery bypass graft on (b)(6) 2019 and suture was used.The suture pulled off from the needle during continuous suturing on the vein.It was not a control release needle.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 11/20/2019.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional device evaluated by mfr: one empty opened overwrap, a labeled winding former, one detached needle and a needle-suture in two section were received for analysis.The product code is double armed.During the visual inspection of detached needle, the swage and attachment area were as expected.The barrel hole was examined under magnification and remnant suture was noted.The suture end is severely cut (damaged), resulting in a clip off defect.In the inspection of the needle/suture combination, the swage and attachment area were as expected.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the sample condition the assignable cause of the performance ¿ needle pull off, is a clip off defect, this defect is caused by excessive pressure on the suture during swaging of the needle and consequently breaking.

• Brand Name: PRLNE HS BLU 36IN 3-0 D/A RB-1
• 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: 9246662
• Report Number: 2210968-2019-89109
• Device Sequence Number: 13564691
• Product Code: GAW
• UDI-Device Identifier: 10705031022843
• UDI-Public: 10705031022843
• 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): 10/02/2019

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: 05/31/2023
• Device Catalogue Number: 9556H
• Device Lot Number: MGQ656
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2019
• Initial Date Received by Manufacturer: 10/02/2019
• Supplement Date Received by Manufacturer: 11/01/2019
• Initial Report FDA Received Date: 10/28/2019
• Supplement Report FDA Received Date: 11/20/2019
• Patient Sequence Number: 1