MAUDE Adverse Event Report: ETHICON INC. MCRYL UD 18IN 6-0 S/A P-1 PRM; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	Y489G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Attempts have been 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 a patient underwent an unknown procedure on (b)(6) 2019 and suture was used.The needle detached from the suture.There were no adverse consequences for the patient reported.
Additional Manufacturer Narrative
(b)(4).The actual device was received for analysis as a paper lid, an empty winding former and a dispensed suture of product code y489.During the visual inspection of the suture , the end is severely cut, resulting in a clip off defect.In addition, the needle was not returned.Per the sample condition the assignable cause of the performance pull off suture needle, is a clip off defect, this defect is caused by excessive pressure on the suture during swaging of the needle and consequently breaking.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: MCRYL UD 18IN 6-0 S/A P-1 PRM
• 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: 8416029
• Report Number: 2210968-2019-79428
• Device Sequence Number: 11165814
• Product Code: GAN
• UDI-Device Identifier: 10705031059313
• UDI-Public: 10705031059313
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K964072
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/28/2019

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: 03/31/2023
• Device Catalogue Number: Y489G
• Device Lot Number: MDZ876
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2019
• Initial Date Received by Manufacturer: 02/14/2019
• Supplement Date Received by Manufacturer: 03/28/2019; 03/28/2019
• Initial Report FDA Received Date: 03/13/2019
• Supplement Report FDA Received Date: 03/29/2019; 04/24/2019
• Patient Sequence Number: 1