MAUDE Adverse Event Report: ETHICON INC. PDS II SUTURE 36"(90CM) 1 VIO; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	Z347H
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/10/2018
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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Did any piece of the needle fall inside of the patient? if so, was the needle piece removed and how? when did the needle pull off (while in the package / during dispensing / during preparation / during use)?.
Event or Problem Description
It was reported that the patient underwent a sigmoidectomy procedure on (b)(4) 2018 and suture was used.It was reported that suture detached from the needle swage during passage through tissue.The procedure was completed with a like device.There were no patient consequences reported.No additional information is available.
Additional Manufacturer Narrative
(b)(4).Additional evaluation summary: the actual sample was returned for analysis.During the visual inspection of the sample, the insertion end was measured and did not meet the requirement.In addition, the needle was not returned for evaluation.This defect is caused because the insertion of the suture in the needle was insufficient from keeping the needle/suture union during transportation or use.
Additional Manufacturer Narrative
Pc-(b)(4).

• Brand Name: PDS II SUTURE 36"(90CM) 1 VIO
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• MDR Report Key: 7237296
• Report Number: 2210968-2018-70636
• Device Sequence Number: 13480535
• Product Code: NEW
• UDI-Device Identifier: 10705031060685
• UDI-Public: 10705031060685
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: N18331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/10/2018

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: 05/31/2021
• Device Catalogue Number: Z347H
• Device Lot Number: KGZ363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2018
• Initial Date Received by Manufacturer: 01/10/2018
• Supplement Date Received by Manufacturer: 01/10/2018; 02/14/2018
• Initial Report FDA Received Date: 02/02/2018
• Supplement Report FDA Received Date: 02/02/2018; 02/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1