MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 18IN 3-0 S/A PS-2 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J497G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device pcz244 batch number, and no non-conformances were identified.Additional information was requested and the following was obtained: confirm the specific number of devices (total qty actually involved with reported issue) that failed during this one patient reported event / one procedure ? 5 of the sutures were affected.The customer returned the remaining 7.Investigation summary: seven unopened samples of product code j497, lot pcz244 were returned for evaluation.The complaint sample was not received for analysis.During the visual inspection of seven unopened samples, no defects were found on the packages.The samples were opened, and the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along of the strand and no defects, damaged or suture breakage were noted.A functional test was performed and the tensile strength force was above the minimum requirement.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the representative samples, no breakage suture was found and the tested samples met the finished goods requirements.Note: events reported via mw 2210968-2019-87657, 2210968-2019-87658, 2210968-2019-87659, 2210968-2019-87660, 2210968-2019-87661.
Event or Problem Description
It was reported that the patient underwent an unknown procedure on an unknown date and suture was used.During the procedure, the suture broke.It is unknown if another like device was used to complete the procedure.There were no adverse consequences for the patient reported.

• Brand Name: VCL CT BRD UD 18IN 3-0 S/A PS-2 PRM MP
• 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: 9076071
• Report Number: 2210968-2019-87658
• Device Sequence Number: 2976305
• Product Code: GAM
• UDI-Device Identifier: 10705031040625
• UDI-Public: 10705031040625
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/20/2019

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: 02/29/2024
• Device Catalogue Number: J497G
• Device Lot Number: PCZ244
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/20/2019
• Initial Report FDA Received Date: 09/17/2019
• Patient Sequence Number: 1