MAUDE Adverse Event Report: ETHICON INC. VCL+ UD 8X18IN 3-0 S/A SHB CR; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCPB864D
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.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.The following information was requested, but unavailable: did the needle piece fell inside of the patient? if so, what was done to retrieve the broken piece? no further information is available.Was additional dissection required in other organs/tissues other than the target tissue? no.What tissue was being sutured when the event occurred? no further information is available.Could you please provide the lot number? no further information is available.Procedure name and date? no further information is available.(b)(4).
Event or Problem Description
It was reported that a patient underwent an unknown surgery on an unknown date and suture was used.During the procedure, it was reported that the needle tip broke.The surgeon commented that the grip position might have been bad.No device left in the patient¿s body.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Date sent to the fda: 07/14/2021 the manufacturing records could not be reviewed as the batch number is unknown.Additional h-3 summary: a failed suture needle was submitted for fractographic evaluation.The component was identified as product code vcpb864d.A fracture was observed near the tip of the needle.The needle was received in two pieces, only one of the mating fracture surfaces was examined for this evaluation.The evaluation revealed the fracture was composed of microvoid coalescence, which is evidence of a ductile fracture mode.This was a ductile fracture.The evidence of this examination indicates that the breakage occurred at the tip of the needle during use due to tensile overload.There is no evidence of any material flaw or defect that would cause premature failure.In order to avoid this kind of damage grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the attachment end to the point.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.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, 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.Date sent to the fda: 07/14/2021 corrected information: d7a, d9.

• Brand Name: VCL+ UD 8X18IN 3-0 S/A SHB CR
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11856531
• Report Number: 2210968-2021-04806
• Device Sequence Number: 19823918
• Product Code: GAM
• UDI-Device Identifier: 10705031056664
• UDI-Public: 10705031056664
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K032420
• 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,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2021

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 Model Number: VCPB864D
• Device Catalogue Number: VCPB864D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2021
• Initial Date Received by Manufacturer: 04/23/2021
• Supplement Date Received by Manufacturer: 06/21/2021
• Initial Report FDA Received Date: 05/20/2021
• Supplement Report FDA Received Date: 07/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1