MAUDE Adverse Event Report: ETHICON INC. ETHLN BLK 18IN 2-0 S/A PS PRM; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	585H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no nonconformances were identified.Investigation summary: it was reported that the device had performance breakage needle.It was received for analysis an opened box with eleven unopened samples.During the visual inspection of the samples, no defects were found on the packages.The samples were opened, and the swage and attachment area were noted to be as expected.No needles breakage was observed.The sutures were dispensed without problems and examined along of the strand and no defects were observed.Also, the sample was tested by resistance test to needle and met the requirements.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the conditions of the sample received, no performance breakage needle were found.Representative samples returned to support investigation of 3 device issues captured in 2210968-2019-85907, 2210968-2019-85908, and 2210968-2019-85909.Analysis results have been included in reports for each.
Event or Problem Description
It was reported that a patient underwent a lesion excision from the left leg on (b)(6) 2019 and suture was used.During the procedure, the tip of needle broke off while approximating the skin in the leg.The broken needle tip was retrieved and discarded.Additional suture from the same box was used to complete the procedure.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
Date sent to the fda: 09/06/2019 additional h-3 summary: only a picture of the sample was received for evaluation.Upon visual inspection of the picture, a broken needle could be observed.However, no conclusion could be reach as the sample was not returned.

• Brand Name: ETHLN BLK 18IN 2-0 S/A PS PRM
• 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: 8915077
• Report Number: 2210968-2019-85907
• Device Sequence Number: 1829381
• Product Code: GAR
• UDI-Device Identifier: 10705031006393
• UDI-Public: 10705031006393
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2019

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: 01/31/2023
• Device Catalogue Number: 585H
• Device Lot Number: MBQ373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2019
• Initial Date Received by Manufacturer: 07/25/2019
• Supplement Date Received by Manufacturer: 09/04/2019
• Initial Report FDA Received Date: 08/21/2019
• Supplement Report FDA Received Date: 09/06/2019
• Patient Sequence Number: 1