MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 2X24IN 7-0 D/A BV175-6 EP; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	EPM8737
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).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 an unknown cardiovascular surgery on an unknown date and suture was used.The suture was broken during use.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).Device evaluation summary: actual device received: it was received for analysis a needle-suture piece and two sutures pieces of product code epm8737.During visual inspection of the needle-suture piece, the swage and attachment area were noted to be as expected, and the end of suture pieces were observed cut appears to be by use of a surgical instrument.Additionally, a functional test was performed and the tensile strength force was above the minimum requirement.The manufacturing records couldn¿t be reviewed as the batch number is unknown.Due to the sample condition, the assignable cause of performance breakage suture, was suggests an improper handling of the sample.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.Unused sample: it was received for analysis a folder with a undispensed needle-suture of product code epm8737.During the visual inspection of open sample; the swage and attachment area were noted to be as expected.The suture was dispensed without problems and examined along of the strands and no defects were observed.A functional test was performed on the sample and the tensile force met the requirements.The manufacturing records couldn¿t be reviewed as the batch number is unknown.Per the condition of the opened sample, no performance breakage suture was observed, and the tested sample meet the finished goods requirements.

• Brand Name: PRLNE BLU 2X24IN 7-0 D/A BV175-6 EP
• 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: 8541131
• Report Number: 2210968-2019-80623
• Device Sequence Number: 16576956
• Product Code: GAW
• UDI-Device Identifier: 10705031207479
• UDI-Public: 10705031207479
• 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,Followup
• Report Date (Section B): 03/28/2019

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 Catalogue Number: EPM8737
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2019
• Initial Date Received by Manufacturer: 03/28/2019
• Supplement Date Received by Manufacturer: 06/26/2019; 06/26/2019
• Initial Report FDA Received Date: 04/23/2019
• Supplement Report FDA Received Date: 06/26/2019; 06/26/2019
• Patient Sequence Number: 1