MAUDE Adverse Event Report: ETHICON INC. EB EXC GRN 36IN 0 D/A V-7; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	X905H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # = > (b)(4).A manufacturing record evaluation was performed for the finished device batch qkmatl, x905h and no non-conformances were identified.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.The single complaint was reported with multiple events.There are no additional details regarding the additional events.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.¿ how many devices were used in this procedure? ¿ how the broken needle were retrieved from the patient? ¿ what was the current status of the patient? ¿ how many devices will be returning? ¿ please provide procedure name.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that the patient underwent an unknown surgery on (b)(6) 2021 and the suture was used.It was reported that the needle was broken during the second passage through the patient's skin to fix the drain.There were no patient consequences.Additional information requested.
Additional Manufacturer Narrative
(b)(4).Date sent to fda: 03/19/2021.Additional information was requested and the following was obtained: how the broken needle were retrieved from the patient? no piece of needle fell into the patient.What was the current status of the patient? the patient is doing well.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.

• Brand Name: EB EXC GRN 36IN 0 D/A V-7
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 11345990
• Report Number: 2210968-2021-01572
• Device Sequence Number: 3478922
• Product Code: GAT
• UDI-Device Identifier: 10705031058279
• UDI-Public: 10705031058279
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2021

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: 08/31/2025
• Device Model Number: X905H
• Device Catalogue Number: X905H
• Device Lot Number: QKMATL
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/26/2021
• Supplement Date Received by Manufacturer: 02/24/2021
• Initial Report FDA Received Date: 02/18/2021
• Supplement Report FDA Received Date: 03/19/2021
• Patient Sequence Number: 1