MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 8X18IN 5-0 S/A RB-1 CR MP; SUTURES - ABSORBABLE

Catalog Number	Z711D
Medical Device Problem Codes	Break (1069); Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device llk497 batch number, and no non-conformance 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 pancreaticoduodenectomy on (b)(6) 2019 and suture was used.During interrupted suturing on the digestive tract, the suture was broken when tying a knot.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
(b)(4).It was reported a breakage suture issue.One empty opened foil, two used needle, a needle-suture in several pieces and one winding former with five needle-suture combinations were received for analysis.During the visual inspection of two detached needles, the swage and attachment area the swage and attachment area were noted to be as expected and a suture piece still was attached to barrel of needles.Also, the needle-suture pieces were examined, and the suture has begun with the process of degradation.The winding former was visually inspected, and five needle-sutures could not be dispensed since has begun with the process of degradation and this condition caused that the suture was broken.The time of exposure of sutures to the environment could not be determined.Also, the foil was examined and showed multiples wrinkles and holes in cavity on bottom foil packet due to excessive manipulation.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the samples, the assignable cause of performance breakage suture, is suture degradation; due to the improper handling of package.

• Brand Name: PDSII VIO 8X18IN 5-0 S/A RB-1 CR MP
• Common Device Name: SUTURES - ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 9109781
• Report Number: 2210968-2019-88018
• Device Sequence Number: 19773685
• Product Code: NEW
• UDI-Device Identifier: 10705031061590
• UDI-Public: 10705031061590
• 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): 08/28/2019

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: 09/30/2022
• Device Catalogue Number: Z711D
• Device Lot Number: LLK497
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2019
• Initial Date Received by Manufacturer: 08/28/2019
• Supplement Date Received by Manufacturer: 10/01/2019
• Initial Report FDA Received Date: 09/24/2019
• Supplement Report FDA Received Date: 10/28/2019
• Patient Sequence Number: 1