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	06/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).A manufacturing record evaluation was performed for the finished device pcz921 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.This medwatch report is in response to receipt of voluntary medwatch event report, no number provided.
Event or Problem Description
It was reported that the patient underwent an unknown procedure on (b)(6) 2019 and the suture was used.During suturing of the fascia, a tip of the needle broke off and was not found.Ap and lateral abdominal x-rays were negative for needle.There were no patient consequences reported.
Additional Manufacturer Narrative
Additional summary: received an empty opened foil, an empty folder and a detached needle of product code z371, lot pcz921 for fractographic 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.The evaluation revealed the fracture was composed of microvoid coalescence, which is evidence of a ductile overload failure.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.In order to avoid this kind of damage grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the attachment end to the point.
Additional Manufacturer Narrative
(b)(4).The product upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.

• 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: 8818382
• Report Number: 2210968-2019-84595
• Device Sequence Number: 10848470
• 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: health professional,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/26/2019

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: Z371T
• Device Lot Number: PCZ921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2019
• Initial Date Received by Manufacturer: 06/26/2019
• Supplement Date Received by Manufacturer: 09/10/2019; 10/17/2019
• Initial Report FDA Received Date: 07/23/2019
• Supplement Report FDA Received Date: 10/07/2019; 11/11/2019
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 56