MAUDE Adverse Event Report: ETHICON INC. EB EXC 5GRN/5WHT 30IN 2-0 D/A RB-1; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	10X42
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/14/2019
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 a patient underwent an unknown cardiovascular surgery on (b)(6) 2019 and suture was used.During the procedure, the suture detached from the needle.There were no adverse consequences to the patient.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Device evaluation summary: the actual device was received for evaluation as two needles of product code 10x42 were returned for analysis.The product code is multi-strand double armed.During the visual inspection of two needles, the swage and attachment area were noted to be as expected; however marks on the edge of a needle that appears to be by the use of a surgical instrument was noted.The suture was dispensed without problems and examined along of the strands and no defects were observed.Per the sample condition the assignable of the performance pull off suture needle, suggest an improper handling of the sample.The manufacturing records couldn¿t be reviewed as the batch number is unknown.Representative sixteen re-parked needle-suture pieces and a needle-suture combination in a opened folder of product code 10x42 were returned for analysis.The product code is multi-strand double armed.During the visual inspection of sixteen needle-suture piece (eight samples), the swage and attachment area were noted to be as expected and a suture piece still was attached to barrel needle.In addition, the end of the suture was cut appears to be by use of the surgical instrument and no needle pull off was noted.Due to the condition of the sample the functional test can¿t be performed.The suture was 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.Per the condition of nine samples, no performance pull off suture needle was found, and the tested sample met the finished goods requirements.

• Brand Name: EB EXC 5GRN/5WHT 30IN 2-0 D/A RB-1
• 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: 8499505
• Report Number: 2210968-2019-80196
• Device Sequence Number: 16816759
• Product Code: GAT
• UDI-Device Identifier: 10705031001275
• UDI-Public: 10705031001275
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K946173
• 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
• Report Date (Section B): 03/14/2019

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: 10X42
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2019
• Initial Date Received by Manufacturer: 03/14/2019
• Supplement Date Received by Manufacturer: 04/15/2019
• Initial Report FDA Received Date: 04/10/2019
• Supplement Report FDA Received Date: 05/03/2019
• Patient Sequence Number: 1