MAUDE Adverse Event Report: ETHICON INC. MCRYL UD 36IN 2-0 S/A CT-1; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	Y945H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device phm853 batch number, and no non-conformances were identified attempts are being made to receive a device for evaluation.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.What is the name of the initial procedure? were x-rays taken to locate the needle piece(s)? was the needle piece(s) retrieved during the same procedure? device return follow up.This medwatch report is in response to receipt of maude event report mw#5093177.
Event or Problem Description
It was reported that the patient underwent an unknown procedure on (b)(6) 2020 and the suture was used.During suturing incision, the needle broke in half and the broken portion fell into surgical site.Broken half of needle was retrieved from surgical site.Additional information has been requested.

• Brand Name: MCRYL UD 36IN 2-0 S/A CT-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: 9934185
• Report Number: 2210968-2020-02723
• Device Sequence Number: 754592
• Product Code: GAN
• UDI-Device Identifier: 10705031059962
• UDI-Public: 10705031059962
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K964072
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/10/2020

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: Y945H
• Device Catalogue Number: Y945H
• Device Lot Number: PHM853
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2020
• Initial Report FDA Received Date: 04/08/2020
• Patient Sequence Number: 1