MAUDE Adverse Event Report: ETHICON INC. ETHLN BLK 18IN 4-0 S/A P-3 PRM MP; SUTURE, NONABSORBABLE, SYNTHETIC

Model Number	699G
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
(b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.The following information was requested, but unavailable: were there any unexpected outcomes or complications as a result of the prolonged surgery time? =>no further information is available.Was the patient treatment altered in anyway due to the prolonged surgery time? if yes, please explain =>no further information is available.Patient¿s current status? =>no further information is available.Please provide lot number =>no further information is available.Please provide event date =>no further information is available.Please provide procedure date =>no further information is available.No further information will be provided.
Event or Problem Description
It was reported that a patient underwent an unknown cardiologic surgery on an unknown date and suture was used.During the procedure, the suture was detached from the needle during use on the epidermis.It was not a control release needle.The operation time was extended within 30 minutes.The lot number is unknown.There were no adverse patient consequences reported.Additional information was requested.

• Brand Name: ETHLN BLK 18IN 4-0 S/A P-3 PRM MP
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10712245
• Report Number: 2210968-2020-08177
• Device Sequence Number: 14323351
• Product Code: GAR
• UDI-Device Identifier: 10705031008625
• UDI-Public: 10705031008625
• 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
• Report Date (Section B): 10/12/2020

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 Model Number: 699G
• Device Catalogue Number: 699G
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/12/2020
• Initial Report FDA Received Date: 10/21/2020
• Patient Sequence Number: 1