MAUDE Adverse Event Report: ETHICON INC. VCL+ UD 8X18IN 2-0 S/A CP-2 CR; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCP762D
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that a patient underwent a spinal procedure on (b)(6) 2019 and suture was used.During a spin "pocket reversion" the tip of the needle broke off inside the patient.The tip was found and removed from the patient and the procedure was completed with a like device from a different lot with no patient consequences.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 06/30/2020.A manufacturing record evaluation was performed for the finished device lot qcmdqc, and no non-conformances were identified.Additional investigation summary: an opened sample and ten unopened samples were received for evaluation.During the visual inspection of an opened sample, the swage and attachment area of eight needles were noted to be as expected.No breakage needle on tip, body or swage area was noted.During the visual inspection of ten representative samples, no defects were found on the packages.The samples were opened, and the swage and attachment area were noted to be as expected.No needles breakage was observed on body, tip or swage area.The sutures were dispensed without problems and examined along of the strand and no defects were observed.Also, the samples were tested by resistance test to needle and met the requirements.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the conditions of the samples received, no performance breakage needle were found.

• Brand Name: VCL+ UD 8X18IN 2-0 S/A CP-2 CR
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10188881
• Report Number: 2210968-2020-04786
• Device Sequence Number: 947911
• Product Code: GAM
• UDI-Device Identifier: 10705031055391
• UDI-Public: 10705031055391
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K032420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2020

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: 02/28/2025
• Device Model Number: VCP762D
• Device Catalogue Number: VCP762D
• Device Lot Number: QCMDQC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2020
• Initial Date Received by Manufacturer: 06/10/2020
• Supplement Date Received by Manufacturer: 06/26/2020
• Initial Report FDA Received Date: 06/24/2020
• Supplement Report FDA Received Date: 06/30/2020
• Patient Sequence Number: 1