MAUDE Adverse Event Report: ETHICON INC. ETHILON SUTURE 5"(13CM) 9-0 BLK; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	2809G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts are being 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 or Problem Description
It was reported that the patient underwent an unknown surgery on an unknown date and suture was used.The suture broke during surgery.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 1/8/2020.Additional information: d10, h6.Additional h3 investigation summary: one re-parked needle-suture piece inside folder of product code 2809 was received for analysis.During the visual inspection of the sample, the swage and attachment area were noted to be as expected.The suture was examined along of the strand and damaged and the end cut appears to be by use of surgical instrument could be observed.A functional test was performed and the tensile strength force was above the minimum requirement.The manufacturing records could not be reviewed as the batch number is unknown.According to the sample condition it was suggest an improper handling of the sample.

• Brand Name: ETHILON SUTURE 5"(13CM) 9-0 BLK
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9355519
• Report Number: 2210968-2019-90083
• Device Sequence Number: 2403472
• Product Code: GAR
• UDI-Device Identifier: 10705031003958
• UDI-Public: 10705031003958
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K946173
• 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,Followup
• Report Date (Section B): 10/27/2019

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 Catalogue Number: 2809G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2019
• Initial Date Received by Manufacturer: 10/27/2019
• Supplement Date Received by Manufacturer: 12/12/2019
• Initial Report FDA Received Date: 11/21/2019
• Supplement Report FDA Received Date: 01/08/2020
• Patient Sequence Number: 1