MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 8"(20CM) 3-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	8534H
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.The product upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Event or Problem Description
It was reported that a patient underwent an aaa anastomosis on an unknown date and suture was used.During the procedure, the thread was noticed to be frayed.It had not come into contact with any instruments to cause fraying.There were no adverse patient consequences were reported.No additional information was provided.The surgeon opined there was potential significant harm to patient if suture thread was weakened and had come apart post-operatively.
Additional Manufacturer Narrative
(b)(4).Additional information was requested and the following was obtained: for this case reported, there were mentions of "potential significant harm to patient if suture thread was weakened and had come apart post-operatively." can we please confirm if this statement if by yourself or the user/surgeon? this was from the end user.Did the surgeon used another suture to complete or did the surgeon decide to continue using the reported device that's been frayed? the surgeon used another suture.In addition, since the case was reported, has there been any patient consequence reported for this case? no.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 11/04/2019.It was reported performance fraying suture intra-op.A labeled winding former with two needle/suture pieces and two sutures pieces were received for evaluation.During the visual inspection of two needle/sutures, the swage and attachment area were noted to be as expected.Body fluids and marks by use of a surgical instrument could be observed.In addition, a suture piece was noted attach to needles and present damaged and elongation by surgical instrument.Two section of the suture were noted fraying and with elongation due to use.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.Per the condition of the sample received, the assignable cause of the performance fraying suture intra-op is an improper handling.

• Brand Name: PROLENE SUTURE 8"(20CM) 3-0 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: 9256909
• Report Number: 2210968-2019-89248
• Device Sequence Number: 2055042
• Product Code: GAW
• UDI-Device Identifier: 10705031016774
• UDI-Public: 10705031016774
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 10/04/2019

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: 10/31/2022
• Device Catalogue Number: 8534H
• Device Lot Number: LMB723
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2019
• Initial Date Received by Manufacturer: 10/04/2019
• Supplement Date Received by Manufacturer: 10/30/2019; 11/05/2019
• Initial Report FDA Received Date: 10/30/2019
• Supplement Report FDA Received Date: 11/04/2019; 11/06/2019
• Patient Sequence Number: 1