MAUDE Adverse Event Report: ETHICON INC. MCRYL+ VIO 27IN 3-0 S/A SH; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	MCP316H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).A manufacturing record evaluation was performed for the finished device (b)(4) number, and no non-conformances were identified.To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.Additional information was requested, and the following was obtained: any adverse patient consequences? not reported.What medical/surgical intervention was performed to manage them? required longer ga time to look for the needle, believed to have been located and then dropped on the floor as it was so small.Is the actual sample available and being returned for evaluation? no.When did it happened? (b)(6) 2019.Needle tip did it fall into patient ? yes.Was it retrieved from patient? no.Is patient going to go back in to have it remove: no.The procedure was a labioplasty.
Event or Problem Description
It was reported that the patient underwent a labiaplasty procedure on (b)(6) 2019 and the suture was used.During suturing, needle tip broke and it required longer ga time to look for the needle, which has been located and then dropped on the floor as it was so small.There were no patient consequences reported.

• Brand Name: MCRYL+ VIO 27IN 3-0 S/A SH
• 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: 8819921
• Report Number: 2210968-2019-84599
• Device Sequence Number: 2838950
• Product Code: GAM
• UDI-Device Identifier: 10705031046368
• UDI-Public: 10705031046368
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 06/27/2019

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: 07/31/2019
• Device Catalogue Number: MCP316H
• Device Lot Number: LJM797
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/27/2019
• Initial Report FDA Received Date: 07/23/2019
• Patient Sequence Number: 1