MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 8X18IN 0 S/A CTB-1 CR; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	ZB740
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device pck406 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 an unknown procedure on (b)(6) 2019 and suture was used.When the surgeon was holding the needle by a needle-holder, the needle was broken at the body part.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
(b)(4).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 over stressing of the needle. there is no evidence of any material flaw that would cause premature failure.

• Brand Name: PDSII VIO 8X18IN 0 S/A CTB-1 CR
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8972656
• Report Number: 2210968-2019-86702
• Device Sequence Number: 3295163
• Product Code: NEW
• UDI-Device Identifier: 10705031062108
• UDI-Public: 10705031062108
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: N18331
• 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): 08/13/2019

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: 02/29/2024
• Device Catalogue Number: ZB740
• Device Lot Number: PCK406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2019
• Initial Date Received by Manufacturer: 08/13/2019
• Supplement Date Received by Manufacturer: 09/19/2019
• Initial Report FDA Received Date: 09/06/2019
• Supplement Report FDA Received Date: 10/15/2019
• Patient Sequence Number: 1