MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 8X18IN 3-0 S/A RB-1 CR; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J713D
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Investigation summary: a failed suture needle was submitted for fractographic evaluation.Upon evaluation, a fracture was observed at small portion of the body of sample c.A microscope was used to examine the fracture surface and surrounding area of the needle.The evaluation revealed the fracture were composed of microvoid coalescence, which is evidence of a ductile overload failure.Mechanical damage observed coincidental to the fracture provides additional evidence that the failure was induced by mechanical deformation leading to ductile overload.This was a ductile fracture.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.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.Additional information was requested and the following was obtained: were there any unexpected outcomes or complications as a result of the prolonged surgery time? no further information is available.Was the patient treatment altered in anyway due to the prolonged surgery time? if yes, please explain.No further information is available.Device return status / follow up: when we send the sample to you, we will let you know its return date and tracking number.No further information will be provided.Note: events reported in 2210968-2019-87985 and 2210968-2019-87986.
Event or Problem Description
It was reported that a patient underwent an unknown urological surgery on (b)(6) 2019 and suture was used.There were no adverse consequences to the patient.Upon evaluation, a returned needle was found broken.No additional information was provided.

• Brand Name: VCL CT BRD VIO 8X18IN 3-0 S/A RB-1 CR
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 9109621
• Report Number: 2210968-2019-87987
• Device Sequence Number: 11659658
• Product Code: GAM
• UDI-Device Identifier: 10705031042469
• UDI-Public: 10705031042469
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/27/2019

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: 09/30/2023
• Device Catalogue Number: J713D
• Device Lot Number: MLK032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/27/2019
• Initial Report FDA Received Date: 09/24/2019
• Patient Sequence Number: 1