MAUDE Adverse Event Report: ETHICON INC. SFX SPI PDS+ UNI VIO 12IN 0 S/A CT-2; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number	SXPP1B405
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	06/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device mmj813, and no non-conformance's 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.Additional information was requested and the following was obtained: how was the needle being held during use? the needle was held correctly not at the needle-suture attachment, but at 3/4 from the tip.Was there any anomaly or issue with the device prior to use? no, the patient had 2 miomas, and dr sutured the first one with a stratafix of the same code and batch with the same instruments.Were all of the needle pieces removed from the patient? yes.What is the status of device return for evaluation? awaiting for release from the pharmacy.What are the patient age, weight and bmi? (b)(6) kg, don't know the height but she wasn't obese.What is the current condition of the patient? ok, at home.
Event or Problem Description
It was reported that the patient underwent laparoscopic myomectomy on (b)(6) 2019 and suture was used on the uterus.On the last passage, the needle broke and two-thirds of needle went into the uterus.An xray was performed to localize the needle.Once the needle was localized into the uterine tissue, an incision was made laterally with the biggest trocar (12 mm) creating an incision of more than 50 mm to elevate the uterus and touch with hands to find and remove the needle.The needle was retrieved and removed from the uterus and operation completed successfully.The current patient status is reported to be at home.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 10/30/2019.It was reported performance needle breakage.A failed suture needle was submitted for fractographic evaluation.A fracture was observed in the body of the needle.The needle was received in two pieces, only one of the mating fracture surfaces was examined 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.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.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 from mechanical deformation, indents and scratches, due to gripping, bending and overstressing of the needle.  there is no evidence of any material flaw that would cause premature failure.

• Brand Name: SFX SPI PDS+ UNI VIO 12IN 0 S/A CT-2
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8736668
• Report Number: 2210968-2019-83314
• Device Sequence Number: 2572912
• Product Code: NEW
• UDI-Device Identifier: 10705031236080
• UDI-Public: 10705031236080
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K150670
• 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
• Report Date (Section B): 06/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: SXPP1B405
• Device Lot Number: MMJ813
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2019
• Initial Date Received by Manufacturer: 06/04/2019
• Supplement Date Received by Manufacturer: 10/03/2019
• Initial Report FDA Received Date: 06/26/2019
• Supplement Report FDA Received Date: 10/30/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 37 YR
• Patient Weight: 56