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

Catalog Number	MCP497G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device pam077 number, and no non-conformances were identified.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.Confirm the specific number of devices (total qty actually involved with reported issue) that failed during this one event report/procedure? did the suture thread break into 2 pieces close to the swage location or did the whole suture thread pull off / detach at the swage location causing it to separate from the needle? any patient consequence? was procedure completed successfully? and how?.
Event or Problem Description
It was reported that the patient underwent an unknown procedure on (b)(6) 2019 and suture was used.The thread broke away from needle at swage with skin closure.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 09/10/2019.It was reported that this device is not malfunction reportable.Therefore, this medwatch report is not reportable.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 event report/procedure? one.Did the suture thread break into 2 pieces close to the swage location or did the whole suture thread pull off / detach at the swage location causing it to separate from the needle? whole suture detached at swage.Any patient consequence? no.Was procedure completed successfully? and how? yes.New suture opened.Note: event has been reported via mw submission 2210968-2019-82934.

• Brand Name: MCRYL+ 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: 8712081
• Report Number: 2210968-2019-82933
• Device Sequence Number: 14103426
• Product Code: GAM
• UDI-Device Identifier: 10705031046603
• UDI-Public: 10705031046603
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K050845
• 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,Followup
• Report Date (Section B): 05/23/2019

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: 12/31/2020
• Device Catalogue Number: MCP497G
• Device Lot Number: PAM077
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/23/2019
• Supplement Date Received by Manufacturer: 08/14/2019
• Initial Report FDA Received Date: 06/19/2019
• Supplement Report FDA Received Date: 09/10/2019
• Patient Sequence Number: 1