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

Catalog Number	Z117H
Medical Device Problem Code	Component Incompatible (1108)
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 device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.
Event or Problem Description
It was reported that a patient underwent an unknown surgery on an unknown date and suture was used.It was found that the suture near the swage part was too thin when opening the package.The needle-suture in question could not be used.There were no adverse consequences to the patient.

• 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: 7658907
• Report Number: 2210968-2018-74030
• Device Sequence Number: 16647157
• Product Code: NEW
• UDI-Device Identifier: 10705031060166
• UDI-Public: 10705031060166
• 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
• Report Date (Section B): 06/07/2018

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: 06/30/2022
• Device Catalogue Number: Z117H
• Device Lot Number: LHM305
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2018
• Initial Report FDA Received Date: 07/03/2018
• Patient Sequence Number: 1