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

Model Number	K883H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint number: (b)(4).Was there any adverse consequence associated with the patient? did the event occur during one or multiple patient procedures? when was the needle pop-off from the suture for all vcp317h involved (in the package, during removal from package, during handling or during use on the patient)? please specify when was the needle pop-off from the suture for all k833h involved (in the package, during removal from package, during handling or during use on the patient)? please specify could you please confirm if 36 vcp317h pop-off intra-operatively? could you please confirm if 26 vcp317h pop-off intra-operatively? what is the lot number? device return status: 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 related to: 2210968-2022-01112.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2022 and suture was used.During the procedure, the suture kept popping off even though it was thought not to be a pop-off.This problem also existed with a silk code as well.There were no patient consequences reported.Additional information was requested.

• Brand Name: SILK BLK 30IN 2-0 S/A BB
• Common Device Name: SUTURE, NONABSORBABLE, SILK
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13539650
• Report Number: 2210968-2022-01113
• Device Sequence Number: 14420038
• Product Code: GAP
• UDI-Device Identifier: 10705031044685
• UDI-Public: 10705031044685
• Combination Product (Y/N): N
• 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): 02/16/2022

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: K883H
• Device Catalogue Number: K883H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2022
• Initial Report FDA Received Date: 02/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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