MAUDE Adverse Event Report: ETHICON INC. MCRYL UD 18IN 4-0 S/A PC-3 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	Y845G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformance's were identified.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 a patient underwent a thoracic tumor excision lymph node dissection in (b)(6) 2019 and suture was used.During the procedure, the suture kept breaking.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).An opened box with eleven samples of product y845, lot # pcz041 were returned for analysis.During the visual inspection of eleven unopened samples, no defects were found on the packages.The samples were opened, and the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along of the strand and no defects, damaged or suture breakage were noted.A functional test was performed and the tensile strength force was above the minimum requirement.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the representative samples, no breakage suture was found and the tested samples met the finished goods requirements.A suture neede (sample b) was returned for evaluation.A fracture was observed at the suture attachment sample b.One needle was received in two pieces, only one of the mating fracture surface was examined for this evaluation.A scanning electron microscope (sem) was used to examine the fracture surface and surrounding area of the needle.The fracture surface was examined in multiple locations in order to determine the fracture mode.The evaluation of (b)(4) revealed the fracture was composed of microvoid coalescence, which is evidence of a ductile overload failure.Mechanical damage and macroscopic plastic deformation observed coincidental to the fracture provide 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.

• Brand Name: MCRYL UD 18IN 4-0 S/A PC-3 PRM MP
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9245205
• Report Number: 2210968-2019-89125
• Device Sequence Number: 16794212
• Product Code: GAN
• UDI-Device Identifier: 10705031059740
• UDI-Public: 10705031059740
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K964072
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2019

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 Expiration Date: 02/29/2024
• Device Catalogue Number: Y845G
• Device Lot Number: PCZ041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2019
• Initial Date Received by Manufacturer: 10/01/2019
• Supplement Date Received by Manufacturer: 11/20/2019
• Initial Report FDA Received Date: 10/28/2019
• Supplement Report FDA Received Date: 11/21/2019
• Patient Sequence Number: 1