MAUDE Adverse Event Report: ETHICON INC. MCRYL UD 27IN 3-0 S/A SH-1; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	Y219H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 a urological procedure on an unknown date and suture was used.The suture was detached from the needle during use.It was not a control release needle.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
(b)(4).Device evaluation summary: one detached needle and one dispensed suture of product code: y219 were received for analysis.During the visual inspection of the needle, the swage and attachment area were noted to be as expected and remnant of the suture was noted into the barrel hole and slightly marks were observed on the edge of the needle that appears to be by the use of a surgical instrument.The dispensed suture was examined the end of the suture is severely damaged appears to be by the use of a surgical instrument.The manufacturing records could not be reviewed as the batch number is unknown.Per the sample condition the assignable of the performance - pull off suture needle, suggest an improper handling of the sample.

• Brand Name: MCRYL UD 27IN 3-0 S/A SH-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9295402
• Report Number: 2210968-2019-89698
• Device Sequence Number: 16634705
• Product Code: GAN
• UDI-Device Identifier: 10705031058606
• UDI-Public: 10705031058606
• 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,Followup
• Report Date (Section B): 10/18/2019

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: Y219H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2019
• Initial Date Received by Manufacturer: 10/18/2019
• Supplement Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 11/08/2019
• Supplement Report FDA Received Date: 12/13/2019
• Patient Sequence Number: 1