MAUDE Adverse Event Report: ETHICON INC. ETHLN CLR 18IN 4-0 S/A P-3 PRM MP; SUTURE, NONABSORBABLE, SYNTHETIC

Model Number	691G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 (b)(6) 2020; and a suture was used.During the procedure, the suture broke.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 05/19/2020.A manufacturing record evaluation was performed for the finished device batch kdh988 and no non-conformances were identified.
Additional Manufacturer Narrative
Product complaint (b)(4).Date sent to the fda: 09/09/2020.Investigation summary : it was reported breakage suture, seven unopened samples were returned for analysis.During the visual inspection of seven 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 observed.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 performance - breakage suture was found and the tested samples met the finished goods requirements.One empty open overwrap, one paper lid and one suture inside a winding former was received for analysis.The needle was not received for evaluation.During visual inspection of the suture, it was dispensed without problem and examined along of the strand and no defects, damaged or suture breakage were observed.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 sample, no performance - breakage suture was found and the tested samples met the finished goods requirements.One empty open overwrap, one paper lid, a detached needle and one suture inside a winding former was received for analysis.During the visual inspection of the sample, the swage and attachment area of detached needle were noted to be as expected.The barrel hole was examined under magnification and remnant suture was noted, the suture end is severely broken, resulting in a clip off defect.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.According to the sample condition and the assignable cause of the performance breakage suture is a clip off defect, this defect is caused by excessive pressure on the suture during swaging of the needle and consequently breaking and due to this condition.

• Brand Name: ETHLN CLR 18IN 4-0 S/A P-3 PRM MP
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9985491
• Report Number: 2210968-2020-03334
• Device Sequence Number: 17264003
• Product Code: GAR
• UDI-Device Identifier: 10705031008434
• UDI-Public: 10705031008434
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K946173
• 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): 03/31/2020

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 Expiration Date: 03/31/2021
• Device Model Number: 691G
• Device Catalogue Number: 691G
• Device Lot Number: KDH988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Initial Date Received by Manufacturer: 03/31/2020
• Supplement Date Received by Manufacturer: 05/15/2020; 08/17/2020
• Initial Report FDA Received Date: 04/22/2020
• Supplement Report FDA Received Date: 05/19/2020; 09/09/2020
• Patient Sequence Number: 1