MAUDE Adverse Event Report: ETHICON INC. SILK BLK 10X30IN 1 NON NDL; SUTURE, NONABSORBABLE, SILK

Model Number	SA87G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (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.Additional information was requested, and the following was obtained: what is the procedure date? (b)(6) 2021.Could you please provide lot number? re2ah.Did the surgery was completed successfully? yes.
Event or Problem Description
It was reported that a patient underwent an orthopedic procedure on (b)(6) 2021 and suture was used.During the procedure, the suture broke.Another like device was used to complete the procedure.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 10/6/2021.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information: d4, h4, h6.Additional h3 investigation summary: actual customer complaint sample or same batch representative sample are not returned.Same batch manufacturer retained sample evaluated for [appearance] and [tensile strength] and no issue found, detail testing data please refers to investigation plan.The root cause of this complaint can¿t be determined, this complaint data will be kept for trend analysis.

• Brand Name: SILK BLK 10X30IN 1 NON NDL
• Common Device Name: SUTURE, NONABSORBABLE, SILK
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12385754
• Report Number: 2210968-2021-07790
• Device Sequence Number: 4699326
• Product Code: GAP
• UDI-Device Identifier: 10705031050303
• UDI-Public: 10705031050303
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 08/04/2021

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: 04/30/2026
• Device Model Number: SA87G
• Device Catalogue Number: SA87G
• Device Lot Number: RE2AH
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/04/2021
• Supplement Date Received by Manufacturer: 09/10/2021
• Initial Report FDA Received Date: 08/30/2021
• Supplement Report FDA Received Date: 10/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1