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

Catalog Number	J417H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.A manufacturing record evaluation was performed for the finished device lot, and no non-conformance's were identified.
Event or Problem Description
It was reported that a patient underwent a hemorrhoidectomy procedure on (b)(6) 2019 and suture was used.While suturing, the end of the needle broke off in the needle driver.Both pieces of the needle were removed from the sterile field.No adverse patient outcome reported.
Additional Manufacturer Narrative
Product complaint # : (b)(4).Evaluation: a failed suture needle was submitted for fractographic evaluation to assess the fracture mode of the failure.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 microscope 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 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 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.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 07/03/2019.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.The product upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.This medwatch report is in response to receipt of facility report # (b)(4).

• Brand Name: VCL CT BRD UD 27IN 2-0 S/A SH
• 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: 8673080
• Report Number: 2210968-2019-82458
• Device Sequence Number: 19342842
• Product Code: GAM
• UDI-Device Identifier: 10705031060821
• UDI-Public: 10705031060821
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/09/2019

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: No Information
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: J417H
• Device Lot Number: PB7790
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2019
• Initial Date Received by Manufacturer: 05/09/2019
• Supplement Date Received by Manufacturer: 06/06/2019; 07/08/2019
• Initial Report FDA Received Date: 06/05/2019
• Supplement Report FDA Received Date: 07/03/2019; 07/31/2019
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 74