MAUDE Adverse Event Report: ETHICON INC. VICRYL PLUS SUTURE 27"(70CM) 0 VIO; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCPP81D
Medical Device Problem Codes	Break (1069); Degraded (1153); Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Investigation summary: it was reported performance breakage suture.An empty opened foil, two suture pieces and a winding former with two re-parked used needles and six needle-suture combinations were returned for analysis.The product code is control release and required eight strands per packet.During the visual inspection of two suture pieces, body fluids were observed along of strands and the ends of suture piece were busted due to the sutures have begun with the degradation process and no functional test could be performed.Six needle-sutures were visually inspected, the swage and attachment area were noted to be as expected.The sutures were dispensed without problems; however, the sutures have begun with degradation process and no functional test could be performed.The foil was examined and showed multiples wrinkles and holes in cavity on bottom foil package 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 sample, the assignable cause of performance breakage suture, is suture degradation; due to the improper handling of package.
Event or Problem Description
It was reported that a patient underwent an open hysterectomy surgery on (b)(6) 2019 and suture was used.During the procedure, the suture broke.Another like device was used to complete the procedure with no adverse patient consequences.No additional information was provided.

• Brand Name: VICRYL PLUS SUTURE 27"(70CM) 0 VIO
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8456494
• Report Number: 2210968-2019-79725
• Device Sequence Number: 2888026
• Product Code: GAM
• UDI-Device Identifier: 10705031056886
• UDI-Public: 10705031056886
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K032420
• 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
• Report Date (Section B): 03/04/2019

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: 11/30/2022
• Device Catalogue Number: VCPP81D
• Device Lot Number: LPZ194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/04/2019
• Initial Report FDA Received Date: 03/27/2019
• Patient Sequence Number: 1