MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 27IN 5-0 S/A FS-2; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J421H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device pc6573 batch number, and no non-conformances were identified.Attempts are being made to retrieve the device.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.Please confirm the lot number of pc6573 and product code of j421h were involved in this single procedure.Did the suture or the needle break during the procedure? procedure name, initial procedure date, device return status?.
Event or Problem Description
It was reported that the patient underwent an unknown procedure on (b)(6) 2020 and suture was used.During the procedure, the device broke while suturing the patient's mouth.There was no patient injury reported and the procedure was able to be completed.Additional information has been requested.

• Brand Name: VCL CT BRD UD 27IN 5-0 S/A FS-2
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10120127
• Report Number: 2210968-2020-04340
• Device Sequence Number: 2153175
• Product Code: GAM
• UDI-Device Identifier: 10705031039711
• UDI-Public: 10705031039711
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: J421H
• Device Catalogue Number: J421H
• Device Lot Number: PC6573
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/28/2020
• Initial Report FDA Received Date: 06/04/2020
• Patient Sequence Number: 1