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
Product complaint #: (b)(4).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: 10712187
• Report Number: 2210968-2020-08176
• Device Sequence Number: 17014856
• 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