MAUDE Adverse Event Report: ETHICON INC. ETHIBOND EXCEL SUTURE 48"(122CM) 0 GRN; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	DC557
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The product upon which this medwatch is based has been received, however, the evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.Attempts are being made to obtain the additional information.To date no response has been provided.If further details are received at the later date a supplemental medwatch will be sent.Please clarify did the needle separate from the suture? did the needle break? how was the needle removed? was the patient brought back to or to have needle removed or was the needle removed during the initial procedure? was there any additional tissue damage as a result of searching for the needle ? was the surgery delayed? was the patient treatment altered in anyway due to the prolonged surgery time? if yes, please explain was there any patient impact (ie.Additional treatment required) and/or adverse patient outcome due to the prolonged surgery? is the lot number available?.
Event or Problem Description
It was reported that the patient underwent a laparoscopic hiatal hernia repair procedure on (b)(6) 2018 and the suture was used.During the procedure, the needle broke off from the suture as the surgeon was removing the needle from the trocar after completing the knot.The needle was found lying on the omentum in the abdomen and was retrieved with no issue.The needle retrieved from the abdomen and surgeon continued suturing until finished with hiatal closure.There were no adverse patient consequences reported.Additional information has been requested.
Additional Manufacturer Narrative
Pc-000203755 date sent to the fda: 07/31/2018 device evaluation summary: a needle/suture piece and two suture pieces of product code dc557 were returned for analysis.During the visual inspection of sample, the swage and attachment area were as expected.The barrel hole was examined under magnification for suture remnant and had still attached a suture piece to barrel hole.No needle pull off was observed.The suture pieces present body fluids and the ends were damaged (dent) that appears to be by the use of a surgical instrument.According the sample condition, no performance - pull off suture needle was observed on the samples.

• Brand Name: ETHIBOND EXCEL SUTURE 48"(122CM) 0 GRN
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7636604
• Report Number: 2210968-2018-73777
• Device Sequence Number: 1946128
• Product Code: GAT
• UDI-Device Identifier: 10705031036543
• UDI-Public: 10705031036543
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2018

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: Health Professional
• Device Catalogue Number: DC557
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2018
• Initial Date Received by Manufacturer: 05/31/2018
• Supplement Date Received by Manufacturer: 07/06/2018
• Initial Report FDA Received Date: 06/25/2018
• Supplement Report FDA Received Date: 07/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1