MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 8X18IN 1 S/A CT-1 CR; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J841D
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Please clarify how the procedure was complete was the needle retained in the patient? if is the needle piece retained in the patient? size of the needle piece retained? are any plans in place to remove the needle piece in future? please provide procedure date patient¿s current 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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.
Event or Problem Description
It was reported that a patient underwent a laminectomy procedure on (b)(6) 2021 and suture was used.During the procedure, per user facility medwatch form (b)(4), the needle broke.C-arm was utilized to find the 2-degree piece needle.The needle piece was found immediately.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Date sent to the fda: 05/14/2021.Attempts are being made to clarify the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Please confirm that the broken needle piece was found during same initial procedure on (b)(6) 2021? how was the procedure completed? patient¿s current status? will be device returned? if yes, please provide a return date or tracking information? attempts are being made to receive a device.To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.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.Date sent to the fda: 05/14/2021.Corrected information: e1, e4.

• Brand Name: VCL CT BRD UD 8X18IN 1 S/A CT-1 CR
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11635203
• Report Number: 2210968-2021-03155
• Device Sequence Number: 11562343
• Product Code: GAM
• UDI-Device Identifier: 10705031043244
• UDI-Public: 10705031043244
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/17/2021

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: 09/30/2025
• Device Model Number: J841D
• Device Catalogue Number: J841D
• Device Lot Number: QLMAXK
• Initial Date Received by Manufacturer: 03/17/2021
• Supplement Date Received by Manufacturer: 05/14/2021; 05/14/2021
• Initial Report FDA Received Date: 04/08/2021
• Supplement Report FDA Received Date: 05/14/2021; 05/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Weight: 89