MAUDE Adverse Event Report: ETHICON INC. VICRYL RAPIDE SUTURE 27"(70CM) 4-0 UND; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VR426
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Device not returned.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.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.Were x-rays taken to locate the needle piece(s)? was there any additional tissue damage as a result of searching for the needle piece? what is current condition of the patient? what tissue structure was it located?.
Event or Problem Description
It was reported that a patient underwent a hand procedure on (b)(6) 2020 and suture was used.During the procedure, the needle broke.The broken needle found and remove from the patient.Another like device was used to complete the surgery.There were no adverse patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 1/15/2021.  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: were x-rays taken to locate the needle piece(s)? no.Was there any additional tissue damage as a result of searching for the needle piece? no.What is current condition of the patient? normal.What tissue structure was it located? unknown.Device return status/follow up? no device was returned.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, 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: VICRYL RAPIDE SUTURE 27"(70CM) 4-0 UND
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 11030382
• Report Number: 2210968-2020-10044
• Device Sequence Number: 17015803
• Product Code: GAM
• UDI-Device Identifier: 10705031134669
• UDI-Public: 10705031134669
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K033746
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2020

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: 01/31/2025
• Device Model Number: VR426
• Device Catalogue Number: VR426
• Device Lot Number: AN2199
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/01/2020
• Supplement Date Received by Manufacturer: 12/22/2020
• Initial Report FDA Received Date: 12/17/2020
• Supplement Report FDA Received Date: 01/15/2021
• Patient Sequence Number: 1
• Patient Age: 50 YR