MAUDE Adverse Event Report: ETHICON INC. ETHILON SUTURE 18"(45CM) 2-0 BLK; SUTURE, NONABSORBABLE, SYNTHETIC

Model Number	664G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 02/18/2020.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 g a breast reduction procedure on (b)(6) 2020 and suture was used.The suture broke and was twisted and appeared ready to break.Another suture was used to complete the case.There were no patient consequences.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 3/13/2020.Additional h3 investigation summary: it was reported breakage suture.One detached needle of product code 664g were returned for analysis.During the visual inspection of the used needle, the swage and attachment area were noted to be as expected.However, marks were observed on the tip and it found distorted due to use.Additionally the suture was not received for evaluation to determined the assignable cause.To avoid this kind of damage: grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the attachment end to the point.A manufacturing record evaluation could not be completed as batch tcj886 is invalid.Due to the suture was not received for evaluation, no conclusion could be reached as to what may have caused the reported incident.Attempts are being made to obtain the following information.  to date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.The lot number provided tcj886 is invalid.Please clarify the lot number of the device.
Additional Manufacturer Narrative
Product complaint # (b)(4).A manufacturing record evaluation was performed for the finished device lot number and no non-conformances were identified.

• Brand Name: ETHILON SUTURE 18"(45CM) 2-0 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: 9721718
• Report Number: 2210968-2020-01250
• Device Sequence Number: 14258127
• Product Code: GAR
• UDI-Device Identifier: 10705031007819
• UDI-Public: 10705031007819
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/23/2020

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: 02/29/2024
• Device Model Number: 664G
• Device Catalogue Number: 664G
• Device Lot Number: PCJ886
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2020
• Initial Date Received by Manufacturer: 01/23/2020
• Supplement Date Received by Manufacturer: 02/21/2020; 03/17/2020
• Initial Report FDA Received Date: 02/18/2020
• Supplement Report FDA Received Date: 03/13/2020; 03/23/2020
• Patient Sequence Number: 1