MAUDE Adverse Event Report: ETHICON INC. PRONOVA SUTURE 24"(60CM) 8-0 BLU; SUTURE, NON ABSORBABLE, SYNTHETIC

Catalog Number	M3739
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device batch peh042 and no non-conformances were identified.Additional information was requested and the following was obtained: the only other info i have from below is that the needles were coming off the suture intra-op.That¿s all i have from the customer.When did the issue occur; in the package/ during dispensing (before use on patient/during actual suturing (use on patient)? please confirm the number of devices that failed during this single procedure; if occurred during actual use on patient.What was the date of the initial procedure? investigation summary: it was received for analysis a sealed box with twelve samples and twenty-two unopened samples of product code m8739, lot peh042.The complaint sample was not returned for evaluation.During the visual inspection of 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 strands and no defects were observed.A functional test was performed and the pull force were above the minimum requirements.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the samples, no pull off suture needle was found, and the tested samples met the finished goods requirements.
Event or Problem Description
It was reported that the patient underwent a cardiovascular procedure on (b)(6) 2019 and suture was used.The needles were pulling off way too easy.There were no adverse patient consequences reported.

• Brand Name: PRONOVA SUTURE 24"(60CM) 8-0 BLU
• Common Device Name: SUTURE, NON ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9555381
• Report Number: 2210968-2020-00135
• Device Sequence Number: 2036180
• Product Code: GAW
• UDI-Device Identifier: 10705031045200
• UDI-Public: 10705031045200
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K001625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/11/2019

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: 04/30/2024
• Device Catalogue Number: M3739
• Device Lot Number: PEH042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2019
• Initial Report FDA Received Date: 01/06/2020
• Patient Sequence Number: 1