MAUDE Adverse Event Report: ETHICON INC. PDSII CLR 18IN 4-0 S/A PS-2 PRM MP; SUTURE, SURGICAL, ABSORBABLE

Model Number	Z496G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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 provide procedure name and date? wound closure, unknown.Please provide lot number? unknown.How many sutures broke before use on patient (pre-op)? none.How many sutures broke during use on patient (intra-op)? 3 packs.How was procedure successfully completed? yes.Events reported in 2210968-2021-12691 and 2210968-2021-12692.
Event or Problem Description
It was reported that a patient underwent a wound closure surgery on an unknown date in 2021 and suture was used.During the procedure, the suture broke.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: PDSII CLR 18IN 4-0 S/A PS-2 PRM MP
• 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: 13024597
• Report Number: 2210968-2021-12690
• Device Sequence Number: 5441644
• Product Code: NEW
• UDI-Device Identifier: 10705031061217
• UDI-Public: 10705031061217
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/17/2021

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 Model Number: Z496G
• Device Catalogue Number: Z496G
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2021
• Initial Report FDA Received Date: 12/17/2021
• 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