MAUDE Adverse Event Report: ETHICON INC. ETHILON SUTURE 12"(30CM) 10-0 BLK; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	9003G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 ophthalmic operation on an unknown date and suture was used.The suture was detached from the needle easily when a scrub nurse holding the needle in usual way.The lot number is unknown.Further details are not provided.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
Product complaint # : (b)(4).Additional evaluation summary: the actual sample was returned for evaluation.An empty opened folder and a foam park with two needles and a suture in two sections of product code 9003 were returned for analysis.During visual inspection of two needles, the swage and attachment area were noted to be as expected.The barrel hole of the needles was examined and no suture remnant was noted.The suture pieces were examined, and only the insertion of a suture piece present residues of epoxy.The manufacturing records couldn¿t be reviewed as the batch number is unknown.

• Brand Name: ETHILON SUTURE 12"(30CM) 10-0 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: 8353696
• Report Number: 2210968-2019-78956
• Device Sequence Number: 19289138
• Product Code: GAR
• UDI-Device Identifier: 10705031022355
• UDI-Public: 10705031022355
• 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): 01/22/2019

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 Catalogue Number: 9003G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2019
• Initial Date Received by Manufacturer: 01/22/2019
• Supplement Date Received by Manufacturer: 01/22/2019
• Initial Report FDA Received Date: 02/20/2019
• Supplement Report FDA Received Date: 03/19/2019
• Patient Sequence Number: 1