MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 4X24IN 7-0 D/A BV175-6 MP; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	M8735
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot mpr845, and no non-conformances were identified.Investigation summary: it was reported pull off - suture needle.Four unopened samples of product code (b)(4), lot mpr845 were returned for analysis.The product code is multi-strand and contains four strands per packet.During visual inspection of four unopened samples, no defects were found on the packages.Samples were opened and contains four strands double armed; the swage and attachment area of four samples were noted to be as expected.The sutures were dispensed without problems and examined along of the strand and no defects or damaged were found.A functional test was performed and the pull force were above the minimum requirements.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the samples, no performance pull off suture needle was found, and the tested samples met the finished goods requirements.
Event or Problem Description
It was reported that a patient underwent a coronary artery bypass graft on (b)(6) 2019 and suture was used.During the procedure, the needle popped off the suture at the swage.The procedure was completed with the other end of the device with no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Date sent to the fda: 01/22/2020.Additional information: h6.Additional h3 device evaluation summary: twelve strands double armed product code m8735, lot mpr845 were returned for analysis.The product code is multi-strand and contains four strands per packet.During visual inspection of twelve strands double armed samples, no defects were found on the packages.The sutures were dispensed without problems and examined along of the strand and no defects or damaged were found.A functional test was performed and the pull force were above the minimum requirements.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the samples, no performance pull off suture needle was found, and the tested samples met the finished goods requirements.

• Brand Name: PRLNE BLU 4X24IN 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: 9473897
• Report Number: 2210968-2019-90940
• Device Sequence Number: 16869729
• Product Code: GAW
• UDI-Device Identifier: 10705031045996
• UDI-Public: 10705031045996
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 11/25/2019

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: 11/30/2023
• Device Model Number: M8735
• Device Catalogue Number: M8735
• Device Lot Number: MPR845
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2019
• Initial Date Received by Manufacturer: 11/25/2019
• Supplement Date Received by Manufacturer: 01/06/2020
• Initial Report FDA Received Date: 12/16/2019
• Supplement Report FDA Received Date: 01/22/2020
• Patient Sequence Number: 1