MAUDE Adverse Event Report: ETHICON INC. MONOCRYL PLUS SUTURE 36"(90CM) 3-0 VIO; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	MCP923H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts have been 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.Lot #? did the suture thread break intra-op? or post-op? can you confirm and provide the specific number of devices (total qty actually involved with reported issue) that failed during use on same patient/ single procedure? was any re-suturing/medical/surgical intervention done on patient post-op initial procedure? please provide the status of the device(s) as it has not been received for analysis.If the device has been shipped, please provide the shipment tracking details.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2019 and suture was used.During the procedure, the skin suture broke multiple times.It is unknown how the case was completed.No patient consequences were reported.Additional information has been requested.

• Brand Name: MONOCRYL PLUS SUTURE 36"(90CM) 3-0 VIO
• 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: 8991147
• Report Number: 2210968-2019-87008
• Device Sequence Number: 2616893
• Product Code: GAM
• UDI-Device Identifier: 10705031046733
• UDI-Public: 10705031046733
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• PMA/510(K) Number: K050845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/15/2019

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 Catalogue Number: MCP923H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/15/2019
• Initial Report FDA Received Date: 09/11/2019
• Patient Sequence Number: 1