MAUDE Adverse Event Report: ETHICON INC. 6-0 PROLENE BLUE 75CM WITH PS-3 PRIME MP; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	F2832
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 the patient underwent a dental procedure on unknown date in (b)(6) 2019 and suture was used.The suture broke during the passage in tissue before making the second knot.Another device from competitor was used to complete the procedure.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: it was reported: suture breakage.Two unopened samples of product code f2830, lot mlh139 was returned for analysis.During the visual inspection of two unopened samples, 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 noted.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 suture breakage was found and the tested samples met the finished goods requirements.One empty labeled winding former and a needle-suture piece of product code f2830, lot mlh139 were returned for analysis.During visual inspection of the needle-suture piece, the swage and attachment area were noted to be as expected, and the end of suture piece was observed cut, which appears to be by use of a surgical instrument.Additionally, the functional test could not 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 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 the suture breakage suggests an improper handling of the sample.

• Brand Name: 6-0 PROLENE BLUE 75CM WITH PS-3 PRIME 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: 8597113
• Report Number: 2210968-2019-81243
• Device Sequence Number: 2075116
• Product Code: GAW
• UDI-Device Identifier: 10705031238046
• UDI-Public: 10705031238046
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/15/2019

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: 09/30/2023
• Device Catalogue Number: F2832
• Device Lot Number: MLH139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2019
• Initial Date Received by Manufacturer: 04/15/2019
• Supplement Date Received by Manufacturer: 05/13/2019; 05/20/2019
• Initial Report FDA Received Date: 05/09/2019
• Supplement Report FDA Received Date: 05/15/2019; 05/30/2019
• Patient Sequence Number: 1