MAUDE Adverse Event Report: ETHICON INC. ETHIBOND EXCEL SUTURE 30"(75CM) 3-0 G/W; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	D9306
Medical Device Problem Code	Material Separation (1562)
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.
Event or Problem Description
It was reported that a patient underwent an unknown surgery procedure on an unknown date and a suture was used.During surgery, the suture was detached from the needle though it was not a control release needle.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 1/30/2019.Evaluation: a detached needle, a needle/suture and a msda folder with five un-dispensed needle/suture combinations were returned for analysis.This product is ten strands double armed per packet.During the visual inspection of detached needle, the swage and attachment area was noted to be as expected.The barrel hole of the needle was examined under magnification and no suture remnant was noted.The suture was examined, and the insertion did not meet the requirement.During the visual inspection of five samples, the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along the strand with no defects, or damaged observed.A functional test was performed and the pull force were above the minimum requirements.The dhr review could not be conducted, because the batch number of the complaint is unknown.Per the condition of the used sample, the assignable cause of the suture needle pull off was a short insertion.This defect is caused because the insertion of the suture in the needle was insufficient from keep the needle/suture union during transportation or use.Per the conditions of the five samples, no suture needle pull off was found, and the tested samples met the finished goods requirements.

• Brand Name: ETHIBOND EXCEL SUTURE 30"(75CM) 3-0 G/W
• 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: 8162490
• Report Number: 2210968-2018-77752
• Device Sequence Number: 2202940
• Product Code: GAT
• UDI-Device Identifier: 10705031032668
• UDI-Public: 10705031032668
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K946173
• 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): 11/20/2018

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: D9306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2019
• Initial Date Received by Manufacturer: 11/20/2018
• Supplement Date Received by Manufacturer: 01/07/2019
• Initial Report FDA Received Date: 12/13/2018
• Supplement Report FDA Received Date: 01/30/2019
• Patient Sequence Number: 1