MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 30"(75CM) 0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	8412H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 gynecological procedure on (b)(6) 2019 and suture was used.During the procedure, the tip of the needle broke off while inside the patient.The tip was found and removed.The procedure was completed with no adverse patient consequences.No additional information was provided.
Additional Manufacturer Narrative
Date sent to the fda: 02/28/2020.Additional information: d10, h6.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances related to the reported complaint condition were identified.Additional h-3 summary: a failed suture needle was submitted for fractographic 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.The evaluation revealed the fracture was composed of microvoid coalescence, which is evidence of a ductile overload failure.Mechanical damage, a cup-and-cone shaped fracture and macroscopic plastic deformation observed coincidental to the fracture provide additional evidence that the failure was induced by mechanical deformation leading to ductile overload.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
Date sent to the fda: 02/28/2020.

• Brand Name: PROLENE SUTURE 30"(75CM) 0 BLU
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9642292
• Report Number: 2210968-2020-00792
• Device Sequence Number: 2139640
• Product Code: GAW
• UDI-Device Identifier: 10705031015265
• UDI-Public: 10705031015265
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/09/2020

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: 11/30/2023
• Device Model Number: 8412H
• Device Catalogue Number: 8412H
• Device Lot Number: MPH428
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2020
• Initial Date Received by Manufacturer: 01/09/2020
• Supplement Date Received by Manufacturer: 02/05/2020; 02/05/2020
• Initial Report FDA Received Date: 01/29/2020
• Supplement Report FDA Received Date: 02/28/2020; 02/28/2020
• Patient Sequence Number: 1