MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 36IN 1 S/A CP-1; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCP474H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device (b)(4), and no non-conformances were identified.The following information was requested and obtained.To date the device has not been returned.If further details are received at a later date a supplemental medwatch will be sent.Were there any unexpected outcomes or complications as a result of the prolonged surgery time? no problem for the patient.Was the patient treatment altered in anyway due to the prolonged surgery time? if yes, please explain no further information is available.Patient¿s current status? no problem for the patient.Is the needle piece retained in the patient? the surgeon searched for the needle fragment by x-ray, but could not find.How was the broken needle retrieved from the patient? no further information is available.Are there any future interventions; including x-ray planned to locate the broken needle tip? no further information is available.Status of device return/follow up, we regularly contact with sales rep about the device returning.No further information will be provided.
Event or Problem Description
It was reported a patient underwent an unknown spinal surgery on (b)(6) 2020 and a suture was used.The surgeon noticed that the needle tip had been missing during subcutaneous suturing by continuous suturing.The operation time was extended within 30 minutes.The surgeon searched for the needle fragment by x-ray, but could not locate.Further details are not provided.There were no adverse consequences to the patient.The surgeon commented: it may have broken because a surgeon in the 4th year of surgery grasped the needle tip strongly with needle forceps during suturing.
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.A fracture was observed at the tip of the needle.One side of the needle was received, the mating fracture surface was not provided 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 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 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.

• Brand Name: VCL+ VIO 36IN 1 S/A CP-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10160417
• Report Number: 2210968-2020-04610
• Device Sequence Number: 3468882
• Product Code: GAM
• UDI-Device Identifier: 10705031053557
• UDI-Public: 10705031053557
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K032420
• 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,Followup
• Report Date (Section B): 06/11/2020

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: 09/30/2023
• Device Model Number: VCP474H
• Device Catalogue Number: VCP474H
• Device Lot Number: ML2445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Initial Date Received by Manufacturer: 06/11/2020
• Supplement Date Received by Manufacturer: 07/22/2020
• Initial Report FDA Received Date: 06/16/2020
• Supplement Report FDA Received Date: 07/27/2020
• Patient Sequence Number: 1