MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 12IN 6-0 D/A S-24; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J552G
Medical Device Problem Code	Degraded (1153)
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
(b)(4).Investigation summary: it was reported that the device had a breakage suture pre-op issue.An empty opened foil, a paper lid, a winding former and a needle-suture combination in two section of product code j552, lot le6999 were returned for analysis.During the visual inspection of the opened sample (two suture pieces), the swage and attachment area of needle were noted to be as expected.The suture pieces were examined and have begun with the process of degradation and this caused breakage suture.The product code j552 contains an absorbable suture 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.Also, the foils were examined and showed multiples wrinkles and holes on bottom foil packages due to excessive manipulation.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the sample, the assignable cause of performance breakage suture, is suture degradation; due to the improper handling of package.A manufacturing record evaluation was performed for the finished device le6999 number, and no non-conformance's were identified.
Event or Problem Description
It was reported that the patient underwent an unknown procedure on an unknown date and suture was used.The staff found that the suture was broken before use.The device was not used on the patient.There were no patient consequences reported.Upon evaluation of the returned device, the suture pieces were examined and have begun with the process of degradation.

• Brand Name: VCL CT BRD VIO 12IN 6-0 D/A S-24
• 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: 8736424
• Report Number: 2210968-2019-83313
• Device Sequence Number: 2271620
• Product Code: GAM
• UDI-Device Identifier: 10705031041172
• UDI-Public: 10705031041172
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K022269
• 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): 06/17/2019

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: 04/30/2022
• Device Catalogue Number: J552G
• Device Lot Number: LE6999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/17/2019
• Initial Report FDA Received Date: 06/26/2019
• Patient Sequence Number: 1