MAUDE Adverse Event Report: ETHICON INC. PDS II SUTURE 36"(90CM) 0 VIO; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	Z346H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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 a laparoscopic cholecystectomy on (b)(6) 2019 and suture was used to make a fascia closure.During the procedure, the surgeon passes point and the needle is broken in half.The procedure was paused and the surgeon looked for the fragment without finding a reason for which wide incision, is sought in cavity and adipose tissue but the fragment is not found.The surgeon palpated the fragment in the plane of adipose tissue but it was not possible to remove it for this reason.The surgeon proceeded to closure of the cavity and an rx plate will be made postoperatively.No reintervention had to be made to the patient.The patient is in good condition.There were no adverse patient consequences reported.No additional information was provided.

• Brand Name: PDS II SUTURE 36"(90CM) 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: 8587758
• Report Number: 2210968-2019-81131
• Device Sequence Number: 1666885
• Product Code: NEW
• UDI-Device Identifier: 10705031060661
• UDI-Public: 10705031060661
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 04/09/2019

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: 09/30/2023
• Device Catalogue Number: Z346H
• Device Lot Number: MLZ253
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/09/2019
• Initial Report FDA Received Date: 05/07/2019
• Patient Sequence Number: 1