MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 4X18IN 4-0 S/A X-1 CR; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	D10057
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 the patient underwent an unknown ob-gyn procedure on (b)(6) 2019, and suture was used.During the procedure, the suture was broken after passing the needle through the dermis.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Additional evaluation summary: it was received for analysis an empty winding former and needle-suture in two section of product code d10057.During the visual inspection of the needle-suture piece, the swage and attachment area were noted to be as expected and the end suture was observed cut appears to be by use of a surgical instrument.Also, suture piece was examined, body fluids were observed and the end match with the needle suture piece.As with any device, care should be taken to avoid damage to the strand when handling.Avoid the crushing or crimping action of the surgical instruments, such as needle holders and forceps.Per the sample condition, the assignable cause suggests an improper handling of the sample.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.

• Brand Name: PDSII VIO 4X18IN 4-0 S/A X-1 CR
• 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: 8780849
• Report Number: 2210968-2019-84103
• Device Sequence Number: 19361769
• Product Code: NEW
• UDI-Device Identifier: 10705031134324
• UDI-Public: 10705031134324
• 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): 06/17/2019

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: 12/31/2023
• Device Catalogue Number: D10057
• Device Lot Number: PAM686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2019
• Initial Date Received by Manufacturer: 06/17/2019
• Supplement Date Received by Manufacturer: 07/30/2019
• Initial Report FDA Received Date: 07/11/2019
• Supplement Report FDA Received Date: 08/23/2019
• Patient Sequence Number: 1