MAUDE Adverse Event Report: ETHICON INC. MCRYL UD 18IN 5-0 S/A PC-3 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	Y844G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint: (b)(4).A manufacturing record evaluation was performed for the finished device ph6813 batch number, and no non-conformance's were identified.Attempts are being made to receive device for evaluation.To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.Additional information was requested, and the following was obtained: the faulty suture was recognized when they were doing the count before the procedure.It was not used on the patient and they just replaced it with another suture.What was the name of the procedure? what is the condition of the patient? what was used to complete the procedure? device return/follow up.
Event or Problem Description
It was reported that the patient underwent an unknown surgery on (b)(6) 2020 and the suture was used.It was reported that when opening suture packet, the suture was not attached to the thread.It was not used on the patient and replaced it with another suture.There was no adverse patient consequence reported.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 04/13/2020.Additional h3 investigation summary: one open sample of product code y844, lot ph6813 was received for analysis.During the visual inspection of detached needle, the swage and attachment area were as expected.The barrel hole was examined under magnification and remnant suture was noted.The suture end is severely cut, resulting in a clip off defect.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.Per the sample condition the assignable cause of the performance ¿ needle pull off, is a clip off defect, this defect is caused by excessive pressure on the suture during swaging of the needle and consequently breaking.

• Brand Name: MCRYL UD 18IN 5-0 S/A PC-3 PRM MP
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9832472
• Report Number: 2210968-2020-02083
• Device Sequence Number: 19554923
• Product Code: GAN
• UDI-Device Identifier: 10705031059726
• UDI-Public: 10705031059726
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K964072
• 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): 02/20/2020

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: 06/30/2024
• Device Model Number: Y844G
• Device Catalogue Number: Y844G
• Device Lot Number: PH6813
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2020
• Initial Date Received by Manufacturer: 02/20/2020
• Supplement Date Received by Manufacturer: 03/19/2020
• Initial Report FDA Received Date: 03/13/2020
• Supplement Report FDA Received Date: 04/13/2020
• Patient Sequence Number: 1