MAUDE Adverse Event Report: ETHICON INC. EB EXC GRN 4X30IN 3-0 D/A RB-1; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	MX552
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (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 a patient underwent an unknown cardiovascular surgery on (b)(6) 2018 and suture was used.The needle was detached from the suture during use.Further details are not provided.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 01/02/2019.Device evaluation summary: an opened folder and a detached needle of product code mx552 were returned for analysis.During the visual inspection of the needle, the swage and attachment area was as expected.The hole of the needle was examined under magnification for suture remnant and none was noted.The needle had a normal swaged.Additionally, there are several marks on the body of needle appears to be by use of a surgical instrument.Also, the suture was not returned to determine the assignable cause.The manufacturing records couldn¿t be reviewed as the batch number is unknown.It could not be determined what may have caused the reported incident.

• Brand Name: EB EXC GRN 4X30IN 3-0 D/A RB-1
• 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: 8130729
• Report Number: 2210968-2018-77504
• Device Sequence Number: 13516117
• Product Code: GAT
• UDI-Device Identifier: 10705031047129
• UDI-Public: 10705031047129
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 11/07/2018

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 Catalogue Number: MX552
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2018
• Initial Date Received by Manufacturer: 11/07/2018
• Supplement Date Received by Manufacturer: 12/17/2018
• Initial Report FDA Received Date: 12/04/2018
• Supplement Report FDA Received Date: 01/02/2019
• Patient Sequence Number: 1