MAUDE Adverse Event Report: ETHICON INC. PRNVA BLU 36IN 4-0 D/A RB-1; SUTURE, NON ABSORBABLE, SYNTHETIC

Model Number	3557H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.During the procedure, when trying to tie the suture after placing the first stitch, it was noted that one side of the needle was missing.It was searched during the surgery, but it could not be found.So, the surgeon judged that the needle had been detached from the suture originally.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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: please clarify when did the needle got separated from the suture, before use on patient (pre-op), during use on patient (intra-op)or after use on patient (post-op)? when trying to tie the suture after putting the 1st stitch, the surgeon noticed that one side of the needle was missing.It is unknown when the needle got separated from the suture.The following information was requested, but unavailable: please provide procedure name and date no further information is available.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.

• Brand Name: PRNVA BLU 36IN 4-0 D/A RB-1
• Common Device Name: SUTURE, NON ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo PR ; *
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13282575
• Report Number: 2210968-2022-00463
• Device Sequence Number: 20058793
• Product Code: GAW
• UDI-Device Identifier: 10705031004504
• UDI-Public: 10705031004504
• Combination Product (Y/N): N
• PMA/510(K) Number: K001625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/18/2022

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: 3557H
• Device Catalogue Number: 3557H
• Device Lot Number: QKBEDS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2021
• Initial Report FDA Received Date: 01/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown