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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. MONOCRYL SUTURE 36"(90CM) 3-0 VIO; SUTURE, ABSORBABLE, SYNTHETIC
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ETHICON INC. MONOCRYL SUTURE 36"(90CM) 3-0 VIO; SUTURE, ABSORBABLE, SYNTHETIC Back to Search Results
Catalog Number Y527H
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 12/01/2017
Type of Reportable Event Malfunction
Additional 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.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
 
Event or Problem Description
It was reported that a patient underwent an unknown procedure and suture was used.During use, the needle was broken.There were no adverse consequences to the patient.No further information is available.
 
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 2/9/2018 two suture needles were evaluated.A fracture was not observed on either needle.
 
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Brand Name
MONOCRYL SUTURE 36"(90CM) 3-0 VIO
Common Device Name
SUTURE, ABSORBABLE, SYNTHETIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville 08876 0151
MDR Report Key7135278
Report Number2210968-2017-71889
Device Sequence Number13678639
Product Code GAN
UDI-Device Identifier10705031059450
UDI-Public10705031059450
Combination Product (Y/N)N
PMA/510(K) Number
K960653
Number of Events Summarized1
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) 12/01/2017
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 Expiration Date05/31/2022
Device Catalogue NumberY527H
Device Lot NumberLGM259
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/23/2018
Initial Date Received by Manufacturer 12/01/2017
Supplement Date Received by Manufacturer01/23/2018
Initial Report FDA Received Date12/20/2017
Supplement Report FDA Received Date02/09/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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