MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 27IN 0 S/A UR-6; SUTURE, SURGICAL, ABSORBABLE

Model Number	D7185
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2022
Type of Reportable Event	Malfunction
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.The following information was requested, but was unavailable: was this issue identified during the procedure? unsure.What was being done when the needle pulled-off (in the package/ removal from package / during passage through tissue )? unsure.Was the needle piece removed from the patient during the same procedure? unknown was there any additional tissue damage as a result of searching for the needle piece?unknown.Was additional dissection required in other organs/tissues other than the target tissue? unknown.Were there any adverse patient consequences? unknown.Procedure name? unknown.Please provide lot number? "no number left with note, just code." 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.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2022 and suture was used.During the procedure, needle came away.There were no patient consequences reported.Additional information was requested.

• Brand Name: PDSII VIO 27IN 0 S/A UR-6
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13723685
• Report Number: 2210968-2022-01664
• Device Sequence Number: 5985832
• Product Code: NEW
• UDI-Device Identifier: 10705031027343
• UDI-Public: 10705031027343
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: N18331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/10/2022

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 Model Number: D7185
• Device Catalogue Number: D7185
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2022
• Initial Report FDA Received Date: 03/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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