MAUDE Adverse Event Report: ETHICON INC. MCRYL VIO 36IN 0 S/A CTX; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	Y398H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pc (b)(4).A manufacturing record evaluation was performed for the finished device lot number pjz880 and no non-conformances related to the reported complaint condition were identified.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.Additional information was requested and the following was obtained: any plans in place to remove the needle piece in the future? - we are not aware of any plans to remove the piece of needle if retained, what is the surgeon¿s opinion of consequences to the patient? - unknown.The surgeon is not an independent contractor.What was the size of the needle used? - 48 mm was more than half the needle retained in the patient? - no, only 2 mm.Procedure and event date? - c-section (as stated below) (b)(6) 2020 this medwatch report is in response to receipt of facility report # 0300360000-2020- 8024.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that a patient underwent a c-section on (b)(6) 2020 and suture was used.During the procedure, after closure, it was noted that the tip of a suture needle had broken off.It was too small of a piece to use x-ray or find it on wound exam.The nurse estimated that the size of the broken tip was at less than 2 mm.There were no adverse patient consequences reported.No additional information was provided.

• Brand Name: MCRYL VIO 36IN 0 S/A CTX
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 11076856
• Report Number: 2210968-2020-10320
• Device Sequence Number: 19492158
• Product Code: GAN
• UDI-Device Identifier: 10705031059092
• UDI-Public: 10705031059092
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K960653
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/08/2020

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: 07/31/2024
• Device Model Number: Y398H
• Device Catalogue Number: Y398H
• Device Lot Number: PJZ880
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2020
• Initial Report FDA Received Date: 12/28/2020
• Patient Sequence Number: 1
• Patient Age: 28 YR
• Patient Weight: 78