MAUDE Adverse Event Report: ETHICON INC. ETHLN BLK 18IN 5-0 S/A C-3; SUTURE, NONABSORBABLE, SYNTHETIC

Model Number	668G
Medical Device Problem Code	Break (1069)
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
Product complaint # (b)(4).Component code: (b)(4) device not returned.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.Please clarify event date along with procedure date.Actual received date is sep 6.Additional information was requested, and the following was obtained: what was the initial procedure? what is the procedure date? (b)(6).Could you please confirm if the patient suffer from any consequence due to the issue (breakage suture)? there was no any consequence occur.Could you please confirm device's availability? it indicates availability unknown.Not available.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformance's were identified.
Event or Problem Description
It was reported that a patient underwent an unknown procedure in 2021 and suture was used.During the procedure, the suture broke.There were no patient consequences reported.Additional information was requested.

• Brand Name: ETHLN BLK 18IN 5-0 S/A C-3
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12577467
• Report Number: 2210968-2021-09211
• Device Sequence Number: 3375462
• Product Code: GAR
• UDI-Device Identifier: 10705031007895
• UDI-Public: 10705031007895
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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
• Report Date (Section B): 10/05/2021

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: 09/30/2025
• Device Model Number: 668G
• Device Catalogue Number: 668G
• Device Lot Number: QLBBJX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 10/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1