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

Catalog Number	Z371T
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.The following information was requested, but unavailable: did the needle detach from the suture thread during use on patient? or was the needle found detached when package was opened? no further information is available.Lot number =>the lot number is unknown.Device return status/follow up: when we send the sample to you, we will let you know its return date and tracking number.No further information will be provided.
Event or Problem Description
It was reported that the patient underwent an unknown procedure on unknown date and suture was used.During the procedure, the suture was detached from the needle.It was unknown what was used to complete the procedure.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Investigation summary: it was reported that the device had performance pull off - suture needle.It was received for analysis an empty folder, a detached needle and a dispensed suture of product code z371.During the visual inspection of the needle the swage and attachment area were noted to be as expected.The barrel hole of the needle was examined under magnification and no suture remnant was noted.The suture was examined, and the insertion did not meet the requirement.The manufacturing records couldn¿t be reviewed as the batch number is unknown.Per the sample condition, the assignable cause of the performance pull off - suture needle is a short insertion.This defect is caused because the insertion of the suture in the needle was insufficient from keep the needle/suture union during transportation or use.

• 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 NJ 08876 0151
• MDR Report Key: 8579248
• Report Number: 2210968-2019-81028
• Device Sequence Number: 19249050
• Product Code: NEW
• UDI-Device Identifier: 10705031060821
• UDI-Public: 10705031060821
• 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): 04/08/2019

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 Catalogue Number: Z371T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2019
• Initial Date Received by Manufacturer: 04/08/2019
• Supplement Date Received by Manufacturer: 05/27/2019
• Initial Report FDA Received Date: 05/03/2019
• Supplement Report FDA Received Date: 06/19/2019
• Patient Sequence Number: 1