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	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot number qhmcdr / x905h56, and no non-conformances related to the reported complaint condition were identified.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.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Additional information was requested, and the following was obtained: no further information available.General issue.The device is in process of shipment.For each lot being reported: how many devices presented the issue of needle breakage? were there any patient consequences? if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate events were submitted via 2210968-2021-01567, and 2210968-2021-01570.
Event or Problem Description
It was reported that the patient underwent an unknown surgery in 2021 and the suture was used.It was reported that the needle broke.No further information is available.

• 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: 11345885
• Report Number: 2210968-2021-01568
• Device Sequence Number: 3478917
• 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
• 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: 07/31/2025
• Device Model Number: X905H
• Device Catalogue Number: X905H
• Device Lot Number: QJMSXP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2021
• Initial Report FDA Received Date: 02/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1