MAUDE Adverse Event Report: ETHICON INC. SILK SUTURE 18"(45CM) 3-0 BLK; SUTURE, NONABSORBABLE, SILK

Model Number	C013D
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Could you please provide product code? what was being done when the suture broke (e.G.Removal from package, during passage through tissue, during tying, post-op, etc.)? what tissue was being approximated or sutured when it broke? procedure name? a manufacturing record evaluation was performed for the finished device; qdbbdzr0 number, and no non-conformances were identified.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2021 and suture was used.During the procedure, the suture broke with little or no force.A new suture was used to complete the case.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: SILK SUTURE 18"(45CM) 3-0 BLK
• Common Device Name: SUTURE, NONABSORBABLE, SILK
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 11509925
• Report Number: 2210968-2021-02439
• Device Sequence Number: 4497963
• Product Code: GAP
• UDI-Device Identifier: 10705031023420
• UDI-Public: 10705031023420
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/23/2021

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: 05/31/2025
• Device Model Number: C013D
• Device Catalogue Number: C013D
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2021
• Initial Report FDA Received Date: 03/17/2021
• Patient Sequence Number: 1