MAUDE Adverse Event Report: ETHICON INC. PDS SUTURE 18"(45CM) 1 VIO; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	D9638
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.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 total hip arthroplasty on (b)(6) 2018 and suture was used.During the procdure, the suture was broken at a knot while knots were tied by interrupted suturing on the fascia using an instrument.There were no adverse consequences to the patient.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).It was reported performance breakage suture.An empty opened foil, two needle-suture pieces and a winding former with six used re-parked needles (slots 1 to 3, 5,7 and 8) were returned for analysis.This product code is control release and contains eight strands per packet.During the visual inspection of two needle-suture piece, the swage and attachment area of needles were as expected and marks were observed on the body needles, and the ends of the sutures were observed cut appears to be by use of a surgical instrument.The other sections of the sutures were not returned.A functional test was performed and the tensile force were above the minimum requirements.Additionally, four used needles (slots 1 to 3, 5,7 and 8) were examined and the swage and attachment area were as expected.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Due to the sample condition, the assignable cause of performance breakage suture, suggests an improper handling of the sample.

• Brand Name: PDS SUTURE 18"(45CM) 1 VIO
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7739594
• Report Number: 2210968-2018-74804
• Device Sequence Number: 19092894
• Product Code: NEW
• UDI-Device Identifier: 10705031033917
• UDI-Public: 10705031033917
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: N18331
• 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): 07/10/2018

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: 10/31/2020
• Device Catalogue Number: D9638
• Device Lot Number: JM6413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• Initial Date Received by Manufacturer: 07/10/2018
• Supplement Date Received by Manufacturer: 09/04/2018
• Initial Report FDA Received Date: 08/01/2018
• Supplement Report FDA Received Date: 10/02/2018
• Patient Sequence Number: 1