MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 27IN 3-0 S/A X-1; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCP460H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 1/22/2020.Evaluation: an open sample of (b)(4), lot # jaz476 was returned for analysis.During the visual inspection of sample, the suture has begun with the process of degradation and the strand was broken in multiples pieces, this is the cause that breakage suture.The (b)(4) contains absorbable sutures and as the sample was received open, the time of exposure of suture to the environment could not be determined and no functional test can be performed due to sample condition.The foil was inspected and multiples holes in cavity were noted.This condition contributed to degradation of the suture.The conditions of the holes could not be determined.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the sample condition the assignable cause of performance breakage suture, was caused by suture degradation exposure to environment and the reported complaint was observed.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformance's were identified.Additional information has been requested and obtained: are these possible lots for hmk384, jaz476? hmk384 is the lot number of the affected device.Besides the product with hmk384, the hospital returned one unopened package with jaz476.We do not know if it has a problem.Anyway, the both packages (opened one with hmk384, and unopened one with jaz476) were shipped was one device from each lot involved in the event? please see the above comment.Status device return, follow-up? the device has been received at sukagawa and shipped.Please check rmao.No further information will be provided.
Event or Problem Description
It was reported that the patient underwent an unknown surgery on (b)(6) 2019 and the suture was used.During the surgery, the suture was broken easily though it was still within the sterility validity period.The rest of sterilization period was 1 month at that time.There were no adverse patient consequences reported.Upon receipt and evaluation: a second sample was returned for analysis and breakage observed.

• Brand Name: VCL+ VIO 27IN 3-0 S/A X-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: 9616608
• Report Number: 2210968-2020-00584
• Device Sequence Number: 16829136
• Product Code: GAM
• UDI-Device Identifier: 10705031053410
• UDI-Public: 10705031053410
• 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
• Report Date (Section B): 01/13/2020

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: 12/31/2019
• Device Model Number: VCP460H
• Device Catalogue Number: VCP460H
• Device Lot Number: JAZ476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2020
• Initial Report FDA Received Date: 01/22/2020
• Patient Sequence Number: 1