MAUDE Adverse Event Report: ETHICON INC. PDS PLUS CLR 18IN 3-0 S/A PS-2 PRM MP; SUTURE, SURGICAL, ABSORBABLE

Model Number	PDP497G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Attempts have been made to retrieve the device.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.The following information was requested, but unavailable: -what is the lot number? this is a combination product, and the event has been reviewed for both the suture and the triclosan.Trade name - irgacare®, active ingredient(s) ¿ triclosan, dosage form ¿ suture/solid/parenteral, strength ¿ = 2360 g/m.Event related to mw # 2210968-2022-03206 and mw # 2210968-2022-03208.
Event or Problem Description
It was reported that a patient underwent an unknown orthopedic procedure on (b)(6) 2022 and suture was used.The suture easily broke during use.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: PDS PLUS CLR 18IN 3-0 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: 14269745
• Report Number: 2210968-2022-03207
• Device Sequence Number: 5908297
• Product Code: NEW
• UDI-Device Identifier: 10705031048447
• UDI-Public: 10705031048447
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K061037
• 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): 05/02/2022

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: PDP497G
• Device Catalogue Number: PDP497G
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2022
• Initial Report FDA Received Date: 05/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown