MAUDE Adverse Event Report: ETHICON INC. SILK BLK 30IN 2-0 S/A SH; SUTURE, NONABSORBABLE, SILK

Model Number	K833H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint number: (b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information was requested, and the following was obtained: what is the lot number? rhbekr.When was the needle detached/pulled off from the suture (in the package, during removal from package, during handling or during use on the patient)? during handling on the patient.Was there any adverse consequence associated with the patient? no.Device return status: shipping soon.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.Related to: 2210968-2021-12353.
Event or Problem Description
It was reported that a patient underwent a gastric bypass procedure on (b)(6) 2021 and suture was used.During the procedure, two sutures had needles pop off.They were retrieved.There were no patient consequences reported.Additional information was requested.

• Brand Name: SILK BLK 30IN 2-0 S/A SH
• Common Device Name: SUTURE, NONABSORBABLE, SILK
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo ; *
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12937052
• Report Number: 2210968-2021-12354
• Device Sequence Number: 11966983
• Product Code: GAP
• UDI-Device Identifier: 10705031044388
• UDI-Public: 10705031044388
• Combination Product (Y/N): N
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/06/2021

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: 06/30/2026
• Device Model Number: K833H
• Device Catalogue Number: K833H
• Device Lot Number: RHBEKR
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2021
• Initial Report FDA Received Date: 12/06/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown