MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 54IN 1 S/A TP-1; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	Z879G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/01/2018
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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Product code (b)(4) is not associated with lot number lk2019.Please provide the correct product code and lot number if available.This medwatch report is in response to receipt of facility report # 2600320000-2018-8054.
Event or Problem Description
It was reported that a patient underwent a debridement and washout of abdominal wall procedure in (b)(6) 2018 and suture was used.During the procedure, the suture end of needle with metal tip broke off during suturing mesh in patient.The metal tip with suture was easily located and removed from the patient.There were no adverse patient consequences reported.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).Date sent to the fda: (b)(4) 2018.Investigation summary a failed suture needle was submitted for evaluation.A fracture was observed in the body of the needle.One side of the needle was received, the mating fracture surface was not provided 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 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 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.Additional information was requested and the following was obtained: product code (b)(4) is not associated with lot number lk2019.Please provide the correct product code and lot number if available.: the lot number is unknown.

• Brand Name: PDSII VIO 54IN 1 S/A TP-1
• 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: 7781716
• Report Number: 2210968-2018-75141
• Device Sequence Number: 2446710
• Product Code: NEW
• UDI-Device Identifier: 10705031061897
• UDI-Public: 10705031061897
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: N18331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2018

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 Catalogue Number: Z879G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2018
• Initial Date Received by Manufacturer: 07/19/2018
• Supplement Date Received by Manufacturer: 09/10/2018
• Initial Report FDA Received Date: 08/14/2018
• Supplement Report FDA Received Date: 09/12/2018
• Patient Sequence Number: 1
• Patient Age: 69 YR