MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 36"(90CM) 4-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	D7768
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 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 an unknown procedure on an unknown date and suture was used.During the procedure, the suture broke when pulling on the needle during use.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
(b)(4) date sent to the fda: 07/29/2020 additional information was requested and the following was obtained: when placing a cannulation, after putting the 1st stitch on the right atrium of the artificial heart, when trying to put the 2nd stitch, the suture was torn to 2 pieces.There is a possibility that the suture was torn because it was caught on something.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 9/1/2020.Additional information: additional h3 investigation summary: it was reported performance breakage suture.An empty opened folder with seven needle/sutures pieces, a needle/suture of product code d7768, lot were received for evaluation.The product code is multistrand count, each folder contains four strands double armed.During the visual inspection of sample, the swage and attachment area of all needles were noted to be as expected.Marks were observed on needles by use of surgical instrument and the suture ends were noted with a lineal cut appears to be by use of a surgical instrument.No functional test could be performed.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 couldn't be reviewed as the batch number is unknown.Per the condition of the sample received, the assignable cause of the performance breakage suture suggest an improper handling.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: PROLENE SUTURE 36"(90CM) 4-0 BLU
• 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: 10209445
• Report Number: 2210968-2020-04908
• Device Sequence Number: 2404471
• Product Code: GAW
• UDI-Device Identifier: 10705031028357
• UDI-Public: 10705031028357
• 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: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/19/2020

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 Model Number: D7768
• Device Catalogue Number: D7768
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Initial Date Received by Manufacturer: 06/19/2020
• Supplement Date Received by Manufacturer: 07/16/2020; 08/17/2020
• Initial Report FDA Received Date: 06/29/2020
• Supplement Report FDA Received Date: 07/29/2020; 09/01/2020
• Patient Sequence Number: 1