MAUDE Adverse Event Report: ETHICON INC. ETHILON SUTURE 12"(30CM) 10-0 BLK; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number 9000G

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.

Event Description

It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.During the procedure, the suture was detached from the needle too easily.It was not a control release needle.There were no adverse consequences to the patient.No additional information was provided.

Manufacturer Narrative

Pc-000202207 date sent to the fda: 07/31/2018 additional information: device evaluation summary: a needle-suture piece was received for analysis.The product code 9000 is double armed.During the visual inspection of the needle-suture piece (sample #1) the swage and attachment area were as expected.The suture was examined and the end of the suture was cut appears to be by use of surgical instrument.The other section (needle-suture piece) was not returned for analysis.A functional test was performed using a instron and the pull force were above the minimum requirements.In the visual inspection of the dispensed suture (sample #2), the ends of the suture were cut appears to be by the use of surgical instruments.The needles were not returned for evaluation.Per the samples condition the assignable of the performance - pull off suture needle, suggest an improper handling of the sample.

• Brand Name: ETHILON SUTURE 12"(30CM) 10-0 BLK
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7634283
• MDR Text Key: 112309391
• Report Number: 2210968-2018-73737
• Device Sequence Number: 1
• Product Code: GAR
• UDI-Device Identifier: 10705031022300
• UDI-Public: 10705031022300
• 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: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9000G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1