MAUDE Adverse Event Report: ETHICON INC. SILK SUTURE 30"(75CM) 4-0 BLK; SUTURE, NONABSORBABLE, SILK

Catalog Number K952H

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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.Additional information was requested and the following was obtained: did all devices had issue during actual use on patient? yes.How was case completed? no information.No further information will be provided.

Event Description

It was reported that a patient underwent a dental graft procedure on an unknown date and suture was used.During the procedure, the needle detached from the suture easily.There were no adverse consequences to the patient.Additional information had been requested.

Manufacturer Narrative

The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.

• Brand Name: SILK SUTURE 30"(75CM) 4-0 BLK
• Type of Device: SUTURE, NONABSORBABLE, SILK
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7515329
• MDR Text Key: 108292861
• Report Number: 2210968-2018-72804
• Device Sequence Number: 1
• Product Code: GAP
• UDI-Device Identifier: 10705031044760
• UDI-Public: 10705031044760
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: K952H
• Device Lot Number: LGP643
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/15/2018
• Date Device Manufactured: 06/13/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1