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

Catalog Number	Y416H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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.Was the needle piece(s) retrieved?; what measures were taken to retrieve the broken piece?; was there any additional tissue damage as a result of searching for the needle piece?; were x-rays taken to locate the needle piece(s)?; at what location was the needle found?; was the patient brought back to or to have needle removed or was the needle removed during the initial procedure?; does a piece of the needle remain in the patient¿s tissue? if yes, what tissue structure is it located?; if retained, what is the surgeon's opinion of consequences to the patient?; what is the lot number?.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and a suture was used.During surgery, the needle broke in the patient.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 12/5/2018.Additional information was requested and the follow was obtained: was the needle piece(s) retrieved? yes.What measures were taken to retrieve the broken piece? at first they couldn¿t find it ¿ but then the surgeon put his hand inside the incision and pushed around the tissue to feel where the needle was- and then pushed on either side until the needle popped out.Was there any additional tissue damage as a result of searching for the needle piece? no.Were x-rays taken to locate the needle piece(s)? no.At what location was the needle found? left buttock.Was the patient brought back to or to have needle removed or was the needle removed during the initial procedure? initial procedure.Does a piece of the needle remain in the patient¿s tissue? if yes, what tissue structure is it located? no.If retained, what is the surgeon's opinion of consequences to the patient? no patient consequence.What is the lot number? no.

• Brand Name: MCRYL UD 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: 8019994
• Report Number: 2210968-2018-76833
• Device Sequence Number: 11111593
• Product Code: GAN
• UDI-Device Identifier: 10705031059122
• UDI-Public: 10705031059122
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K964072
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2018

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: No Information
• Device Catalogue Number: Y416H
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/05/2018
• Supplement Date Received by Manufacturer: 11/08/2018
• Initial Report FDA Received Date: 10/30/2018
• Supplement Report FDA Received Date: 12/05/2018
• Patient Sequence Number: 1