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

Model Number	J497G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 02/12/2020.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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Lot provided was pg908 which is not valid for ethicon product.Can you clarify the lot number of the device that broke?.
Event or Problem Description
It was reported that the patient underwent an unknown procedure in 2020 and suture was used.During the procedure the suture broke.A similar device was used to complete the case.There were no patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Additional information was requested and the following was obtained: the lot involved is pgz908.A manufacturing record evaluation was performed for the finished device pgz908 batch number, and no non-conformances related to the reported complaint condition were identified.

• 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
• MDR Report Key: 9702330
• Report Number: 2210968-2020-01152
• Device Sequence Number: 16875872
• Product Code: GAM
• UDI-Device Identifier: 10705031040625
• UDI-Public: 10705031040625
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 01/21/2020

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: 05/31/2024
• Device Model Number: J497G
• Device Catalogue Number: J497H
• Device Lot Number: PGZ908
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/21/2020
• Supplement Date Received by Manufacturer: 02/19/2020
• Initial Report FDA Received Date: 02/12/2020
• Supplement Report FDA Received Date: 03/11/2020
• Patient Sequence Number: 1