MAUDE Adverse Event Report: ETHICON INC. SILK BLK 30IN 0 S/A SH; SUTURE, NONABSORBABLE, SILK

Model Number	K834H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2021
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.The following information was requested, but was unavailable: was the needle piece removed from the patient during the same procedure? no further information is available.What tissue/location was suturing when pull off occurred? no further information is available.Were there any unexpected outcomes or complications as a result of this suture needle pull off event? no further information is available.Lot number? no further information is available.No further information will be provided.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.
Event or Problem Description
It was reported that a patient underwent an unknown surgery on (b)(6) 2021 and suture was used.During the procedure, the suture had been detached from the needle.It was not a control release needle.There were no patient consequences reported.Additional information was requested.

• Brand Name: SILK BLK 30IN 0 S/A SH
• Common Device Name: SUTURE, NONABSORBABLE, SILK
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12708842
• Report Number: 2210968-2021-10440
• Device Sequence Number: 19209214
• Product Code: GAP
• UDI-Device Identifier: 10705031044418
• UDI-Public: 10705031044418
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/27/2021

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 Model Number: K834H
• Device Catalogue Number: K834H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2021
• Initial Report FDA Received Date: 10/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1