MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 2X24IN 8-0 D/A BV175-7 MP; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	M8767
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.Additional information was requested and the following was obtained: lot number:the lot number is unknown.Confirm the specific number of devices (total qty actually involved with reported issue) that failed during this one reported event /procedure? this event occurred in two packages in the same box.Additional information: during use of the products, one of the 2 needles on the same suture was held with micro bulldog forceps.In the past surgeries in which the same method was used, no suture-breakage had occurred.
Event or Problem Description
It was reported that a patient underwent a cabg procedure on (b)(6) 2019 and suture was used.During a coronary artery bypass graft, the suture was broken during coronary artery anastomosis by continuous suturing though it was used in a usual way.During this operation, the suture was not pulled with excessive force and it did not get caught by instruments/ tools.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 10/07/2019.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional h3: it was reported that the device had performance breakage suture.It was received for analysis an empty opened straight pack with three needle-sutures pieces inserted in a yellow sponge and a suture piece of product code: m8767, lot: mhb549.The product code is multi-strand and contains two strands per packet.During the visual inspection of the sample, the strands were received broken in two section and the suture ends were damaged caused appears to be by use of a surgical instrument could be observed.In addition, a functional test was performed on the sample and the tensile force met the requirements.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 the sample condition, the assignable cause of performance breakage suture, was an improper handling.It was reported that the device had performance breakage suture.It was received for analysis four unopened samples of product code: m8767, lot: mhb549.The product code is multi-strand and contains two strands per packet.During the visual inspection of the sample, no defects were found on the packages.The samples were opened, and the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along of the strand and no defects, damaged or suture breakage were found.A functional test was performed and the tensile strength force was above the minimum requirement.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the representative samples, no performance - breakage suture was found and the tested sample met the finished goods requirements.It was received for analysis an opened sample with a stand of product code: m8767, lot: mhb549.The product code is multi-strand and contains two strands per packet.During the visual inspection of the opened sample, the swage and attachment area were noted to be as expected.The suture was dispensed without problems and examined along of the strand and no defects, damaged or suture breakage were found.A functional test was performed and the tensile strength force was above the minimum requirement.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the opened sample, no performance - breakage suture was found and the tested sample met the finished goods requirements.Representative samples returned to support investigation of 2 device issues captured in reports 2210968-2019-86353 and 2210968-2019-86354.Analysis results have been included in follow-up reports for each.

• Brand Name: PRLNE BLU 2X24IN 8-0 D/A BV175-7 MP
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8939256
• Report Number: 2210968-2019-86353
• Device Sequence Number: 10814445
• Product Code: GAW
• UDI-Device Identifier: 10705031046177
• UDI-Public: 10705031046177
• 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): 08/02/2019

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: No Information
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: M8767
• Device Lot Number: MHB549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2019
• Initial Date Received by Manufacturer: 08/02/2019
• Supplement Date Received by Manufacturer: 09/11/2019
• Initial Report FDA Received Date: 08/28/2019
• Supplement Report FDA Received Date: 10/07/2019
• Patient Sequence Number: 1