MAUDE Adverse Event Report: ETHICON INC. MONOCRYL SUTURE 36"(90CM) 2-0 VIO; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	Y357H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).It was received for analysis an empty opened foil and a needle-suture piece of product code y357h, lot peu128.Upon evaluation, a fracture was observed at the tip of the needle.One side of the needle was received, the mating fracture surface was not provided for this evaluation.A microscope 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.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 tip 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.
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device peu128 batch number, and no non-conformances were identified.Attempts are being 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 cesarean section on (b)(6) and suture was used.The tip of the needle broke off while suturing the peritoneum.The tip was located and removed easily from the patient at the time of the initial surgery without additional intervention.A like device was used to finish the procedure successfully.There was a delay in the procedure.No medical intervention was required.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 4/21/2020.The product upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.

• Brand Name: MONOCRYL SUTURE 36"(90CM) 2-0 VIO
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9842670
• Report Number: 2210968-2020-02154
• Device Sequence Number: 14112558
• Product Code: GAN
• UDI-Device Identifier: 10705031059009
• UDI-Public: 10705031059009
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K960653
• 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): 02/21/2020

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: 04/30/2024
• Device Model Number: Y357H
• Device Catalogue Number: Y357H
• Device Lot Number: PEU128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2020
• Initial Date Received by Manufacturer: 02/21/2020
• Supplement Date Received by Manufacturer: 03/27/2020; 04/22/2020
• Initial Report FDA Received Date: 03/17/2020
• Supplement Report FDA Received Date: 04/21/2020; 05/06/2020
• Patient Sequence Number: 1