MAUDE Adverse Event Report: ETHICON INC. STLESS STEEL SIL 4X18IN 6 S/A CCS; SUTURE, NONABSORBABLE, STEEL

Model Number	M654G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
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.(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.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.It was reported that the "needle was dislodged from the wire while the surgeon was about to use".Did this issue occurred during surgery or prior usage on the patient? was procedure successfully completed? could you please confirm the device's availability for return? if available, please provide the device return status/follow up.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.During the procedure, the needle of steel wire dislodged from the wire while the surgeon was about to use.There were no adverse patient consequences.Additional information has been requested.
Additional Manufacturer Narrative
Date sent to the fda: 05/14/2021.A manufacturing record evaluation was performed for the finished device batch qabhhe, m654g39 and no non-conformances were identified.Additional information was requested, and the following was obtained: it was reported that the "needle was dislodged from the wire while the surgeon was about to use".Did this issue occurred during surgery or prior usage on the patient? it happened during surgery.Was procedure successfully completed? yes.Could you please confirm the device's availability for return? if available, please provide the device return status/follow up.Not available, discarded by the ot staff.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: STLESS STEEL SIL 4X18IN 6 S/A CCS
• Common Device Name: SUTURE, NONABSORBABLE, STEEL
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11685448
• Report Number: 2210968-2021-03490
• Device Sequence Number: 19601306
• Product Code: GAQ
• UDI-Device Identifier: 10705031000063
• UDI-Public: 10705031000063
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2021

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: 12/31/2024
• Device Model Number: M654G
• Device Catalogue Number: M654G
• Device Lot Number: QABHHE
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/24/2021
• Supplement Date Received by Manufacturer: 04/20/2021
• Initial Report FDA Received Date: 04/19/2021
• Supplement Report FDA Received Date: 05/14/2021
• Patient Sequence Number: 1