MAUDE Adverse Event Report: ETHICON INC. PDS II SUTURE 30"(75CM) 6-0 VIO; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	Z127H
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 an unknown surgery on an unknown date and suture was used.During the procedure, the suture detached from the needle.There were no adverse consequences to the patient.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Investigation summary: it was reported performance pull off suture needle.An empty opened foil, two detached needles and a dispensed suture were returned for analysis.During the visual inspection of two detached needles, the swage and attachment area were noted to be as expected.The barrel hole was examined under magnification and remnant suture was noted in a needle.The sutures ends were examined, and an extreme was severely cut (damaged), resulting in a clip off defect, the other end was noted cut appear to be by use of a surgical instrument.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.According to the sample conditions, the assignable cause of the performance pull off suture needle is a clip off defect, this defect is caused by excessive pressure on the suture during swaging of the needle and consequently breaking.
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.

• Brand Name: PDS II SUTURE 30"(75CM) 6-0 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: 8390124
• Report Number: 2210968-2019-79264
• Device Sequence Number: 1724200
• Product Code: NEW
• UDI-Device Identifier: 10705031060227
• UDI-Public: 10705031060227
• 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,Followup
• Report Date (Section B): 02/08/2019

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 Expiration Date: 12/31/2021
• Device Catalogue Number: Z127H
• Device Lot Number: LAZ678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2019
• Initial Date Received by Manufacturer: 02/08/2019
• Supplement Date Received by Manufacturer: 03/05/2019; 03/20/2019
• Initial Report FDA Received Date: 03/05/2019
• Supplement Report FDA Received Date: 03/06/2019; 04/17/2019
• Patient Sequence Number: 1