MAUDE Adverse Event Report: ETHICON INC. ETHILON BLK 30CM M0.2 10/0 TG140-8; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number W1718

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/17/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional information was requested, and the following was obtained: was the suture found damaged/ broken/fray in the package? no, the suture damaged during operation.Was the suture detached from the needle found in the package? no, the suture detached from the needle during operation.What was used to complete the procedure? used the new pack of suture.What is the patient's condition? n/a.What is the procedure's name? cataract surgery.What is the procedure date? (b)(6) 2020.What is the event date? (b)(6) 2020.Investigation summary: it was reported detached needle.One picture was provided for analysis.Upon visual inspection of the pictures, one open box of product code w1718, lot mpr941 could be observed.However, as no needle or suture were noted; no conclusion could be reach as to what may have caused the reported incident.A manufacturing record evaluation was performed for the finished device lot number mpr941, and no non-conformance's were identified.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 a cataract procedure on (b)(6) 2020; and a suture was used.During the procedure, the suture was fragile and detached from the needle.Another like device was used to complete the procedure.There were no adverse patient consequences reported.Additional information was requested.

• Brand Name: ETHILON BLK 30CM M0.2 10/0 TG140-8
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo 00754 ; * 00754
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082183429
• MDR Report Key: 10238863
• MDR Text Key: 198159258
• Report Number: 2210968-2020-05086
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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
• Report Date: 06/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: W1718
• Device Lot Number: MPR941
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1