MAUDE Adverse Event Report: ETHICON INC. EB EXC 5GRN/5WHT 30IN 2-0 D/A V-7 10PLGT; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	D10069
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot number pkz911, and no non-conformances were identified.Investigation summary: one video and two pictures were provided for analysis.Upon visual inspection of the video, it was observed that the needle was separate from the suture intentionally and the force use to detach the needle could not be determined.Also, the pictures were visually inspected, the back of overwrap packet, several needle-suture combinations (green and white sutures) and one needle at a needle holder of product code d10069, lot pkz911 could be observed.However, no conclusion could be reach as the sample was not returned for analysis.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.
Event or Problem Description
It was reported that a patient underwent a valve replacement procedure on (b)(6) 2020 and suture was used.During the procedure, the suture pulled off the needle after finishing the first stitch.Changed another one to complete the surgery.There is no report on patient's injury.No adverse patient consequences were reported, no additional information could be provided.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 06/29/2020.Additional information: d10, h6.Additional h3 investigation summary: a bottom overwrap packet and five needles of product code d10069, lot # pkz911 were received for evaluation.During the visual inspection of five needles, the swage and attachment area were noted to be as expected and no marks by use of a surgical instrument could be observed and no remnant of the suture was observed into the barrel hole.The sutures were not received for evaluation to determine the assignable cause.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the sample condition, it could not be determined what may have caused the reported incident.Note: events reported via mw 2210968-2020-04182, 2210968-2020-04177, 2210968-2020-04178, 2210968-2020-04179, 2210968-2020-04308.
Additional Manufacturer Narrative
(b)(4).The following additional information was received: the involved and return quantity should be 5.Note: events reported via mw 2210968-2020-04182, 2210968-2020-04178, 2210968-2020-04179 and 2210968-2020-04308.

• Brand Name: EB EXC 5GRN/5WHT 30IN 2-0 D/A V-7 10PLGT
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10093961
• Report Number: 2210968-2020-04177
• Device Sequence Number: 19026857
• Product Code: GAT
• UDI-Device Identifier: 10705031134423
• UDI-Public: 10705031134423
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 05/20/2020

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: 08/31/2024
• Device Model Number: D10069
• Device Catalogue Number: D10069
• Device Lot Number: PKZ911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2020
• Initial Date Received by Manufacturer: 05/20/2020
• Supplement Date Received by Manufacturer: 06/02/2020; 06/12/2020
• Initial Report FDA Received Date: 05/27/2020
• Supplement Report FDA Received Date: 06/02/2020; 06/29/2020
• Patient Sequence Number: 1