MAUDE Adverse Event Report: ETHICON INC. SUTURE UNKNOWN; SUTURE, ABSORBABLE, SYNTHETIC

Device Problems Break (1069); Material Frayed (1262)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Lot # ? product code? it is stated " there were four packs of sutures that the needle either broke off with any tension at all or the suture itself was breaking and/or fraying" can you please clarify out of the qty of 4 involved- how many total devices with needle breakage? how many total devices with suture breakage and how many total devices showed only suture fraying? when was this noticed- pre-op? or intra-op? were all 4 reported devices from the same lot? any samples available to be returned for evaluation?.

Event Description

It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.During an unknown procedure, the needle either broke off with any tension at all or the suture itself was breaking and/or fraying.There were no adverse consequences for the patient reported.

Manufacturer Narrative

Date sent to the fda: (b)(4).Corrected information: d3, g1, g2.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: SUTURE UNKNOWN
• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9345022
• MDR Text Key: 167128484
• Report Number: 2210968-2019-90112
• Device Sequence Number: 1
• Product Code: GAK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/10/2020
• Patient Sequence Number: 1