MAUDE Adverse Event Report: ETHICON INC. ETHIBOND EXCEL SUTURE 30"(75CM) 5 GRN; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	MB47G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Was the needle tip or any needle piece found? in the patient? or anywhere near the patient? / or field? confirm the needle or needle piece was not retained in patient? if yes, what tissue structure is the needle piece located? are there any plans to remove the needle? if yes, please indicate date.Any patient consequence or adverse patient outcome / ae report- intra-op or post-op as a result of the event? has there been any medical or surgical intervention performed or planned? is the actual sample being returned for evaluation? patient's current condition? 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 that the patient underwent a petellar tendon reconstruction procedure and suture was used.During the procedure, the needle tip broke off.It is unknown where the needle broke on the second device.X-rays were taken to see if the tip could be located.There was no sign of the needle inside of the patient.A like device was used to complete the procedure with no patient consequences reported.
Additional Manufacturer Narrative
Pc-(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.The actual device was returned for evaluation.A fracture was observed at the suture attachment and near the tip of the sample.The sample was received in three pieces, only one of the mating fracture surfaces was examined for each break.A microscope was used to examine the fracture surfaces and surrounding area of the needles.The fracture surfaces were examined in multiple locations in order to determine the fracture mode.The evaluation revealed the fractures were composed of microvoid coalescence, which is evidence of a ductile overload failure.Mechanical damage observed coincidental to the fractures provides additional evidence that the failures were induced by mechanical deformation leading to ductile overload.These were ductile fractures.The evidence of this examination indicates that the breakage occurred at the attachment and tip 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.An unopened sample was returned for analysis.During the visual inspection of the sample, no defects were found on the package.The sample was opened and the swage and attachment area were as expected; also, the tip and body of the needles were examined under magnification and no defects or needle breakage were observed.The sutures were dispensed without problems and examined along of the strands and no defects or damage were observed.The samples were tested by resistance test to needle and the needles meet the requirements.Per the condition of the representative sample, no needle breakage were found on the sample.

• Brand Name: ETHIBOND EXCEL SUTURE 30"(75CM) 5 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: 7320963
• Report Number: 2210968-2018-71335
• Device Sequence Number: 13490742
• Product Code: GAT
• UDI-Device Identifier: 10705031046283
• UDI-Public: 10705031046283
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2018

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 Expiration Date: 10/31/2022
• Device Catalogue Number: MB47G
• Device Lot Number: LMH727
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2018
• Initial Date Received by Manufacturer: 02/20/2018
• Supplement Date Received by Manufacturer: 03/09/2018
• Initial Report FDA Received Date: 03/07/2018
• Supplement Report FDA Received Date: 04/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1