MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 27IN 1 S/A CT-1; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	Z341H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device pb6882 batch number, and no non-conformances were identified.To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported that the patient underwent an orthopedic procedure in 2019 and the suture was used.During the surgery, the needle broke in two pieces.It is unknown how the case was completed.There were no adverse patient consequences.
Additional Manufacturer Narrative
(b)(4).A suture needle identified as product code z341h was returned for 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 scanning electron microscope (sem) 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 of (b)(4) 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: PDSII VIO 27IN 1 S/A CT-1
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9278924
• Report Number: 2210968-2019-89506
• Device Sequence Number: 2523735
• Product Code: NEW
• UDI-Device Identifier: 10705031060647
• UDI-Public: 10705031060647
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: N18331
• 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): 10/09/2019

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: 01/31/2024
• Device Catalogue Number: Z341H
• Device Lot Number: PB6882
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2019
• Initial Date Received by Manufacturer: 10/09/2019
• Supplement Date Received by Manufacturer: 11/20/2019
• Initial Report FDA Received Date: 11/05/2019
• Supplement Report FDA Received Date: 12/04/2019
• Patient Sequence Number: 1