MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 36IN 1 S/A CTX; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	Z371T
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pc- (b)(4).Additional information: the actual device batch number associated with this event is not known.The possible batch numbers are reported as follows: batch mmm138; expiration date: 10/31/2023.Date of mfg.: 11/01/2018.Batch pcz711.A manufacturing record evaluation was performed for the finished device possible batch number mmm138 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.This report is related to voluntary facility medwatch.
Event or Problem Description
It was reported via voluntary facility medwatch form that the patient underwent lap-assisted sigmoid colectomy on (b)(6) 2019 and suture was used.During the procedure, the suture needle tip broke off into the needle holder.Both pieces of the device were retrieved and removed from the field.Two needles were opened and it is unsure which lot number broke.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
(b)(4).The actual device batch number associated with this event is not known.The possible batch numbers are reported as follows: batch mmm138; expiration date: 10/31/2023.Date of mfg.: 11/01/2018 batch pcz711; expiration date: 02/29/2024.Date of mfg.: 03/14/2019 a manufacturing record evaluation was performed for the finished device possible batch numbers mmm138, pcz711 and no non-conformances were identified.Additional h3 investigation summary: a suture needle was submitted for evaluation.A fracture was observed at the tip of the needle.One side of the needle was received, the mating fracture surface was not provided 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 pc-000483256 revealed the fracture was composed of microvoid coalescence, which is evidence of a ductile overload failure.Mechanical damage observed coincidental to the fracture provides 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 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.

• Brand Name: PDSII VIO 36IN 1 S/A CTX
• 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: 8767335
• Report Number: 2210968-2019-83649
• Device Sequence Number: 2155416
• Product Code: NEW
• UDI-Device Identifier: 10705031060821
• UDI-Public: 10705031060821
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: N18331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2019

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 Catalogue Number: Z371T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2019
• Initial Date Received by Manufacturer: 06/12/2019
• Supplement Date Received by Manufacturer: 07/18/2019
• Initial Report FDA Received Date: 07/08/2019
• Supplement Report FDA Received Date: 08/15/2019
• Patient Sequence Number: 1
• Patient Age: 47 YR