MAUDE Adverse Event Report: ETHICON INC. ETHIBOND EXCEL SUTURE 30"(75CM) 2-0 GRN; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	MX763
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Additional information was requested and the following was obtained: was the defect in the needle noticed when removed from package? yes.Did the needle bend in the middle during use? no.How was case completed? no information.Lot number: no information.No further information will be provided.Investigation summary: an opened sample of product code mx763 was returned for analysis.During the visual inspection of the sample, the shape of needle was distorted, flat and twisted; also appears to be by the use of a surgical instrument and body fluids were noted.In addition, the swage area and needle tip were broken.The assignable cause of the breakage needle cannot be concluded and an additional evaluation is necessary to determine the failure mode.
Event or Problem Description
It was reported that a patient underwent an orthopedic surgery on (b)(6) 2018 and suture was used.During the procedure the needle was found bent.The device was returned for evaluation and it was noted that the needle was broken at the tip and the swage.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
A fracture was observed at the suture attachment of the needle.One side of the needle was received, the mating fracture surface was not provided for this evaluation.The microscopic evaluation of the needle revealed the fracture was composed of microvoid coalescence, which is evidence of a ductile overload failure.Mechanical damage observed coincidental to the fracture provides additional evidence that the failure was induced by mechanical deformation leading to ductile overload.This was a ductile fracture.The evidence of this examination indicates that the breakage occurred at the attachment area of the needle during use due to tensile overload.There is no evidence of any material flaw or defect that would cause premature failure.In order to avoid this kind of damage grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the attachment end to the point.

• Brand Name: ETHIBOND EXCEL SUTURE 30"(75CM) 2-0 GRN
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7519060
• Report Number: 2210968-2018-72841
• Device Sequence Number: 1164625
• Product Code: GAT
• UDI-Device Identifier: 10705031047174
• UDI-Public: 10705031047174
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 04/20/2018

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: MX763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2018
• Initial Date Received by Manufacturer: 04/20/2018
• Supplement Date Received by Manufacturer: 05/22/2018
• Initial Report FDA Received Date: 05/16/2018
• Supplement Report FDA Received Date: 06/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1