MAUDE Adverse Event Report: ETHICON INC. MONOCRYL SUTURE 27"(70CM) 2-0 VIO; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	Y333H
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluation summary: investigation summary: it was reported that the device had performance pull off suture needle pre-op.It was received for analysis a labeled winding former and a detached needle of product code y333.During the visual inspection of the sample, the swage and attachment area of were noted to be as expected.The suture could not be dispensed since it has begun with the process of degradation and this caused that the needle was not attached to the suture.Also, the foil was not returned for evaluation.The product code y333 contains an absorbable suture and as the sample was received open, the time of exposure of suture to the environment could not be determined and no functional test can be performed due to sample condition.The manufacturing records couldn¿t be reviewed as the batch number is unknown.Due to condition of the sample received, it could not be determined what may have caused the reported incident.
Event or Problem Description
It was reported that the patient underwent an unknown ob-gyn procedure on (b)(6) 2019 and suture was used.The suture had been detached from the needle before use and the device was not used on the patient.There were no patient consequences reported.Upon evaluation of the device, the suture could not be dispensed since it has begun with the process of degradation and this caused that the needle was not attached to the suture.

• Brand Name: MONOCRYL SUTURE 27"(70CM) 2-0 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: 8712006
• Report Number: 2210968-2019-82930
• Device Sequence Number: 14119165
• Product Code: GAN
• UDI-Device Identifier: 10705031058798
• UDI-Public: 10705031058798
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K960653
• 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): 05/28/2019

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 Catalogue Number: Y333H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/28/2019
• Initial Report FDA Received Date: 06/19/2019
• Patient Sequence Number: 1