MAUDE Adverse Event Report: ETHICON INC. ETHILON SUTURE 30"(75CM) 3-0 BLK; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	669H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/10/2019
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.
Event or Problem Description
It was reported that the patient underwent an unknown procedure on (b)(6) 2019 and suture was used.During the procedure, the suture came off the swage.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
(b)(4).A manufacturing record review was performed for the finished device batch mph839-669h and no non-conformances were identified.
Additional Manufacturer Narrative
(b)(4).Date sent to fda: 7/2/2019.Additional evaluation summary: the actual sample was returned for evaluation.During the visual inspection of sample, an incorrect swage was noted, since the marks of the swage area were misformed (only a stake instead of double stake) and consequently, a needle pull off defect caused.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the sample condition, the assignable cause of the suture needle pull off is an incorrect swage.

• Brand Name: ETHILON SUTURE 30"(75CM) 3-0 BLK
• 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: 8586353
• Report Number: 2210968-2019-81114
• Device Sequence Number: 11349399
• Product Code: GAR
• UDI-Device Identifier: 10705031007918
• UDI-Public: 10705031007918
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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,Followup
• Report Date (Section B): 04/10/2019

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: 11/30/2023
• Device Catalogue Number: 669H
• Device Lot Number: MPH839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2019
• Initial Date Received by Manufacturer: 04/10/2019
• Supplement Date Received by Manufacturer: 05/08/2019; 06/27/2019
• Initial Report FDA Received Date: 05/07/2019
• Supplement Report FDA Received Date: 05/22/2019; 07/02/2019
• Patient Sequence Number: 1