MAUDE Adverse Event Report: ETHICON INC. EB EXC GRN 30IN 4-0 D/A C-1 + PLGT; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	X726H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The following information was requested, but unavailable: specific number of devices that had their needles pulled off during this procedure.Did all the devices had needle pull off issue during actual use on patient? the reported lot corresponds to silk suture, not ethibond suture.Please clarify the lot number and product code? attempts have been 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 a patient underwent a hand surgery on (b)(6) 2018 and suture was used.While suturing the needles were popped off, staff used unknown number of sutures from the same box to complete the procedure.There were no adverse consequences for the patient.
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.Five unopened samples of product, were returned for analysis.The product is double armed and the issue sample was not received for evaluation.During the visual inspection of five samples, no defects were found on the packages.Samples were opened, and the swage and attachment area were noted to be as expected.Sutures were dispensed without problems and examined along of the strand and no defects, or damaged were observed.A functional test was performed and the pull force were above the minimum requirements.The manufacturing records were reviewed, and the manufacturing/ packaging criteria were met prior to the release of this batch.Per the conditions of the samples received, no performance pull off suture needle were found, and the tested samples met the finished goods requirements.

• Brand Name: EB EXC GRN 30IN 4-0 D/A C-1 + PLGT
• 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: 7952678
• Report Number: 2210968-2018-76449
• Device Sequence Number: 203831
• Product Code: GAT
• UDI-Device Identifier: 10705031057869
• UDI-Public: 10705031057869
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2018

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 Expiration Date: 01/31/2021
• Device Catalogue Number: X726H
• Device Lot Number: KBQ123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2018
• Initial Date Received by Manufacturer: 09/13/2018
• Supplement Date Received by Manufacturer: 10/16/2018
• Initial Report FDA Received Date: 10/10/2018
• Supplement Report FDA Received Date: 11/13/2018
• Patient Sequence Number: 1