MAUDE Adverse Event Report: ETHICON INC. ETHILON BLU 90CM M3 USP2/0::SGLE ARMED FSL; SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE

Catalog Number	F3232G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.Additional information was requested and the following was obtained: did 2 sutures had the issue in 1 procedure? two units (sutures) are implicated for the this procedure.One unit is implicated for another/2nd procedure (captured in separately).When did the needles pull off in the package/during dispensing/ during use on patient (suturing)? during use on animal when performing the cutaneous suture.Specific number of procedures in which the needles pulled off, during (b)(6) 2018.Two procedures during (b)(6).No further information available.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 or Problem Description
It was reported an animal underwent an unknown procedure on an unknown date and suture was used.Needles from the same box pulled off.No further information available.No patient consequences reported.
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).Date sent to the fda: (b)(4) 2018.The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.A labeled winding former with a re-parked needle and a suture piece of product was returned for analysis.During the visual inspection of the detached needle, mark appear to be by use of surgical instrument were noted on the needle and the swage and attachment area of needle was broken, this caused the separation of the needle from the suture.The suture piece was examined, a needle piece still was attached to the suture and damage were observed the manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the sample condition, no attachment defects were noted; however, breakage needle was found, and the assignable cause of the breakage needle cannot be concluded, and an additional evaluation is necessary.The sample was forwarded for further evaluation to determine the failure mode.The product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 12/04/2018.Additional investigation summary: it was reported performance pull off suture needle.A failed suture needle was submitted for fractographic evaluation.A fracture was observed at the suture attachment of the needle.The needle was received in two pieces, only one of the mating fracture surfaces was examined for this evaluation.A scanning electron microscope (sem) was used to examine the fracture surfaces and surrounding area of the needle.The fracture surfaces were examined in multiple locations in order to determine the fracture mode.The evaluation 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 manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.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: ETHILON BLU 90CM M3 USP2/0::SGLE ARMED FSL
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7906035
• Report Number: 2210968-2018-75943
• Device Sequence Number: 13812464
• Product Code: GAR
• UDI-Device Identifier: 10705031238930
• UDI-Public: 10705031238930
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 08/30/2018

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 Expiration Date: 03/31/2022
• Device Catalogue Number: F3232G
• Device Lot Number: LDP873
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2018
• Initial Date Received by Manufacturer: 08/30/2018
• Supplement Date Received by Manufacturer: 09/24/2018; 11/07/2018
• Initial Report FDA Received Date: 09/25/2018
• Supplement Report FDA Received Date: 10/23/2018; 12/04/2018
• Patient Sequence Number: 1