MAUDE Adverse Event Report: ETHICON INC. ETHLN BLK 12IN 10-0 D/A TG160-4; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	7707G
Medical Device Problem Code	Material Separation (1562)
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).Attempts have been made to retrieve the device.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.Additional information was requested and the following was obtained: product code and lot # for both devices in question? i listed the product codes lot numbers on the product inquiry but here they are again -7707g ¿ pgm968, mj6553.Total qty involved- was it same device that was noticed with both reported issues? or 2 different devices with 2 different lots each device? yes it was same device that had issue with the two different lots.Did the reported events/issues occur on single patient /during single procedure? unsure if it happened on same patient.Was procedure completed successfully? yes, procedures were completed successfully.Please provide the status of the device(s) as it has not been received for analysis.If the device has been shipped, please provide the shipment tracking details.I am returning 2 boxes so please replace two boxes back to the account addressed to the contact on the pi.Note: events reported in 2210968-2019-90332.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.During the procedure, the needle came detached from suture easily.The procedure was completed successfully.There were no adverse patient consequences.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device pgm968 batch number, and no non-conformance were identified.Investigation summary: six unopened samples and one sealed box with twelve unopened samples of product code 7707, lot pgm968 were received for analysis.The complaint sample was not returned for evaluation.The product code is double armed.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 strand and no defects or damaged 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 representative samples, no pull off - suture needle was found and the tested samples met the finished goods requirements.

• Brand Name: ETHLN BLK 12IN 10-0 D/A TG160-4
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9377631
• Report Number: 2210968-2019-90331
• Device Sequence Number: 16680825
• Product Code: GAR
• UDI-Device Identifier: 10705031010468
• UDI-Public: 10705031010468
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• 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,Followup
• Report Date (Section B): 11/08/2019

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: 05/31/2024
• Device Catalogue Number: 7707G
• Device Lot Number: PGM968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Initial Date Received by Manufacturer: 11/08/2019
• Supplement Date Received by Manufacturer: 12/03/2019
• Initial Report FDA Received Date: 11/26/2019
• Supplement Report FDA Received Date: 12/10/2019
• Patient Sequence Number: 1