MAUDE Adverse Event Report: ETHICON INC. EB EXC WHT 30IN 2-0 D/A SH-2 + PLGT; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	PX83H
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
(b)(4).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 that a patient underwent a valve replacement procedure on an unknown date; and a suture was used.During the procedure, the suture pulled off the needle.Another like device was used to complete the procedure.There were no adverse patient consequences reported.No additional information could be provided.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 5/14/2020.H3 investigation summary: it was reported performance pull off suture needle.It was received for analysis an empty opened folder and a dispensed needle-suture of product code px83h.This product code is double armed.During the visual inspection of the opened sample, the swage and attachment area of the needle were noted to be as expected.The other needle was not received for evaluation.The suture was examined, and correct insertion marks were observed; however, the force used to detach needle from the suture could not be determined.In addition, a functional test was performed and the pull force were above the minimum requirements.The manufacturing records could not be reviewed as the batch number is unknown.Due to condition of the opened sample, it could not be determined what may have caused the reported incident.

• Brand Name: EB EXC WHT 30IN 2-0 D/A SH-2 + PLGT
• 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: 9995453
• Report Number: 2210968-2020-03468
• Device Sequence Number: 4203288
• Product Code: GAT
• UDI-Device Identifier: 10705031049260
• UDI-Public: 10705031049260
• 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
• Report Date (Section B): 04/22/2020

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 Model Number: PX83H
• Device Catalogue Number: PX83H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2020
• Initial Date Received by Manufacturer: 04/22/2020
• Supplement Date Received by Manufacturer: 05/12/2020
• Initial Report FDA Received Date: 04/24/2020
• Supplement Report FDA Received Date: 05/14/2020
• Patient Sequence Number: 1