MAUDE Adverse Event Report: ETHICON INC. PDS PLUS SUTURE 36"(90CM) 0 VIO; SUTURE, SURGICAL, ABSORBABLE

Model Number	PDP358T
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.(b)(4).A manufacturing record evaluation was performed for the finished device lot number qamalp / pdp358t23, and no non-conformances related to the reported complaint condition were identified.The device is not being returned.If the device or further details are received at a later date a supplemental medwatch will be sent.(b)(6).
Event or Problem Description
It was reported that the patient underwent an unknown procedure on (b)(6) 2021, and suture was used.The suture broke at the time of knotting when sewing.Changed to another device to complete the surgery.No additional information could be provided.There were no adverse patient consequences reported.

• Brand Name: PDS PLUS SUTURE 36"(90CM) 0 VIO
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 11368928
• Report Number: 2210968-2021-01725
• Device Sequence Number: 858879
• Product Code: NEW
• UDI-Device Identifier: 10705031048171
• UDI-Public: 10705031048171
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/01/2021

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 Expiration Date: 12/31/2021
• Device Model Number: PDP358T
• Device Catalogue Number: PDP358T
• Device Lot Number: QAMALP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2021
• Initial Report FDA Received Date: 02/23/2021
• Patient Sequence Number: 1
• Patient Age: 74 YR