MAUDE Adverse Event Report: ETHICON INC. ETHILON SUTURE 5"(13CM) 9-0 BLK; SUTURE, NONABSORBABLE, SYNTHETIC

Model Number	2809G
Medical Device Problem Code	Break (1069)
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.
Event or Problem Description
It was reported that the patient underwent an unknown procedure in 2019 and suture was used.The suture broken easily during use.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 02/05/2020.A manufacturing record evaluation was performed for the finished device batch pah960 number and no non-conformances were identified.H3 device evaluation summary: it was received for analysis an empty opened overwrap and a empty opened folder of product code 2809, lot pah960.As no needle or suture were returned for evaluation, we are unable to investigate further to the issue of ¿the suture broken easily".The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.According to the sample condition, the cause could not be determined.

• Brand Name: ETHILON SUTURE 5"(13CM) 9-0 BLK
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9470275
• Report Number: 2210968-2019-90918
• Device Sequence Number: 11529737
• Product Code: GAR
• UDI-Device Identifier: 10705031003958
• UDI-Public: 10705031003958
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 11/23/2019

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: 12/31/2023
• Device Model Number: 2809G
• Device Catalogue Number: 2809G
• Device Lot Number: PAH960
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/23/2019
• Supplement Date Received by Manufacturer: 01/15/2020
• Initial Report FDA Received Date: 12/13/2019
• Supplement Report FDA Received Date: 02/05/2020
• Patient Sequence Number: 1