MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 27IN 1 S/A CP; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP480H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).The photo 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.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date in 2019 and suture was used.The needle tip breakage was noted during capsular anchoring.Intra- op wound exploration and x-ray screening showed no corresponding needle tip retention.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).A manufacturing record evaluation was performed for the finished device pa2685, and no non-conformances were identified.Device evaluation summary: there was no sample received for analysis.Only a picture of the sample was received for analysis.Upon visual inspection of the picture, a needle broken at the tip could be observed.However, no conclusion could be reach as the sample was not returned for analysis.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.The cause could not be determined and no further investigation can be conducted since the sample was not returned.

• Brand Name: VCL+ VIO 27IN 1 S/A CP
• 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: 9125883
• Report Number: 2210968-2019-88158
• Device Sequence Number: 14085359
• Product Code: GAM
• UDI-Device Identifier: 10705031053595
• UDI-Public: 10705031053595
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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): 09/02/2019

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: 12/31/2023
• Device Catalogue Number: VCP480H
• Device Lot Number: PA2685
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/02/2019
• Supplement Date Received by Manufacturer: 10/03/2019
• Initial Report FDA Received Date: 09/26/2019
• Supplement Report FDA Received Date: 10/30/2019
• Patient Sequence Number: 1