MAUDE Adverse Event Report: ETHICON INC. PROLENE SUT 30IN(75CM) 1 BLU; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	8435H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformance were identified.Additional evaluation summary: the actual sample was returned for evaluation.A fracture was observed at the tip 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 predominately 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 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.
Event or Problem Description
It was reported that a patient underwent a hysterectomy procedure on (b)(6) 2019 and suture was used.The case was completed successfully.There were no adverse patient consequences reported.Additional information was requested.

• Brand Name: PROLENE SUT 30IN(75CM) 1 BLU
• 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: 8659049
• Report Number: 2210968-2019-82152
• Device Sequence Number: 11337506
• Product Code: GAW
• UDI-Device Identifier: 10705031015623
• UDI-Public: 10705031015623
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K133356
• 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
• Report Date (Section B): 05/15/2019

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: No Information
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 8435H
• Device Lot Number: MMH228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/15/2019
• Initial Report FDA Received Date: 05/31/2019
• Patient Sequence Number: 1