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).(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 2210968-2021-12690 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.
Additional Manufacturer Narrative
(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 2210968-2021-12690 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: 13024608
• Report Number: 2210968-2021-12691
• Device Sequence Number: 20064987
• 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

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