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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. VICRYL SUTURE 18"(45CM) 1 VIO; SUTURE, ABSORBABLE, SYNTHETIC
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ETHICON INC. VICRYL SUTURE 18"(45CM) 1 VIO; SUTURE, ABSORBABLE, SYNTHETIC Back to Search Results
Catalog Number J741D
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 04/17/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(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.
 
Event or Problem Description
It was reported that the patient underwent an unknown orthopedic procedure on (b)(6) 2019 and suture was used.The tip of the needle broke when closing the incision.The tip of the needle was not found.A post op x-ray was performed and unknown if foreign objects were found.It was not reported how the procedure was completed.There were no adverse patient consequences reported.
 
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Brand Name
VICRYL SUTURE 18"(45CM) 1 VIO
Common Device Name
SUTURE, ABSORBABLE, SYNTHETIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
MDR Report Key8609184
Report Number2210968-2019-81383
Device Sequence Number19406509
Product Code GAM
UDI-Device Identifier10705031042650
UDI-Public10705031042650
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
PMA/510(K) Number
K022269
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 04/18/2019
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 NumberJ741D
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 04/18/2019
Initial Report FDA Received Date05/14/2019
Patient Sequence Number1
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