MAUDE Adverse Event Report: ETHICON INC. MCRYL UD 18IN 4-0 S/A PC-12 PRM; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	Y814G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot number an9159 / y814g and no non-conformances related to the reported complaint condition were identified.(b)(4).Summary: upon visual inspection of the one picture received to ethicon inc for evaluation, it was observed an opened foil package product code y814.The reported condition was not observed in the picture.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.No conclusion could be reached as to what caused the reported complaint since the sample was not returned for analysis.Additional information was requested, and the following was obtained: did a piece of the broken needle fell inside the patient? if so, was it retrieved during the same procedure? response: not.What was done to retrieve the broken piece? response: rx done.Piece was not inside the patient.The piece was found outside the surgical field.Was additional dissection required in other organs/tissues other than the target tissue? - response: not.If the needle remains in the patient, please specify size of the needle piece retained, in what structure/tissue was retained and if there are any future plans to remove it.Response: not applicable.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 the patient underwent a c-section on (b)(6) 2021 and the suture was used.During the procedure, the needle broke when passing the skin suture.The piece was not inside the patient.The piece was found outside the surgical field.The procedure was completed successfully.There were no patient consequences reported.

• Brand Name: MCRYL UD 18IN 4-0 S/A PC-12 PRM
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12419070
• Report Number: 2210968-2021-08016
• Device Sequence Number: 3576694
• Product Code: GAN
• UDI-Device Identifier: 10705031059610
• UDI-Public: 10705031059610
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K964072
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/05/2021

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: 08/31/2025
• Device Model Number: Y814G
• Device Catalogue Number: Y814G
• Device Lot Number: AN9159
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2021
• Initial Report FDA Received Date: 09/02/2021
• Patient Sequence Number: 1