MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 27IN 0 S/A CT-2; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J270H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 02/19/2020.A manufacturing record evaluation was performed for the finished device pj4790, and no non-conformance's were identified.Device evaluation summary: a suture needle was submitted for evaluation.A fracture was observed in the body of the needle.The needle was received in two pieces, only one of the mating fracture surfaces was examined for this evaluation.A scanning electron microscope (sem) was used to examine the fracture surfaces and surrounding area of the needle.The fracture surfaces were examined in multiple locations in order to determine the fracture mode.The evaluation revealed the fracture was composed of microvoid coalescence, which is evidence of a ductile overload failure.Mechanical damage, a cup-and-cone shaped fracture and macroscopic plastic deformation observed coincidental to the fracture provide 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 from mechanical deformation, indents and scratches, due to gripping, bending and overstressing of the needle.  there is no evidence of any material flaw that would cause premature failure.
Event or Problem Description
It was reported that the patient underwent a laparoscopic cholecystectomy procedure on (b)(6) 2020 and suture was used.While closing the umbilical fascia, unknown loop, and the needle broke in half while suturing.X-ray was performed to locate and retrieve the broken pieces.All broken pieces were retrieved from the patient.Additional suture was used to complete the procedure.There were no patient consequences reported.

• Brand Name: VCL CT BRD UD 27IN 0 S/A CT-2
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9729606
• Report Number: 2210968-2020-01289
• Device Sequence Number: 2928129
• Product Code: GAM
• UDI-Device Identifier: 10705031038455
• UDI-Public: 10705031038455
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/24/2020

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: 07/21/2024
• Device Model Number: J270H
• Device Catalogue Number: J270H
• Device Lot Number: PJ4790
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2020
• Initial Report FDA Received Date: 02/19/2020
• Patient Sequence Number: 1