MAUDE Adverse Event Report: ETHICON, LLC PDS; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Model Number Z879G

Device Problem Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/09/2018

Event Type  malfunction  

Event Description

Suture end of needle with metal tip broke off during suturing mesh in pt.Metal tip with suture was easily located and removed from pt.

• Brand Name: PDS
• Type of Device: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• Manufacturer (Section D): ETHICON, LLC; route 22 west p.o. box 151; somerville NJ 08876
• MDR Report Key: 7530502
• MDR Text Key: 108805977
• Report Number: 7530502
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: Z879G
• Device Catalogue Number: Z879G
• Device Lot Number: LK2019
• Other Device ID Number: PDS #1
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/10/2018
• Event Location: Hospital
• Date Report to Manufacturer: 05/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 69 YR