MAUDE Adverse Event Report: ETHICON INC. PDSII CLR 27IN 4-0 S/A FS-2; SUTURE, SURGICAL, ABSORBABLE

Model Number	Z422H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2001
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.A manufacturing record evaluation was performed for the finished device km7628 and no non conformances/manufacturing irregularities related to the malfunction were identified 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 product was not returned for evaluation.Visual inspection was conducted on two pictures received.Visual analysis of the pictures received determined that an empty opened box, two empty labeled winding former, a detached needle, and two sutures pieces that appear to be broken of product code z422 could be observed; however, the assignable cause of the reported condition cannot be determined in the picture.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.No conclusion could be reached as to what caused the reported complaint since the sample was not returned for analysis.It should be noted that as part of our quality process, each batch is randomly inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.Additional information was requested and the following was obtained: what was the name of the procedure? breast procedure lift/reduction what was the procedure date? (b)(6) 2021.Did the suture break or did the suture separate from the needle? suture separated from needle entirely.What was used to complete the procedure? additional sutures from the same lot.In relation to needle, what is the approximate location of suture breakage? the needle broke off completely.What tissue was being approximated or sutured when it broke? breast tissue.Was there any adverse consequence associated with the patient? none at all.Device return status: they currently have the 2 broken sutures waiting to ship back.Note: event reported in 2210968-2021-06925.
Event or Problem Description
It was reported that a patient underwent a breast procedure lift/reduction on (b)(6) 2021 and suture was used.During the procedure, the suture was torn.It was clarified that the suture separated from needle entirely.Another like device was used.There were no adverse patient consequences.No additional information was provided.

• Brand Name: PDSII CLR 27IN 4-0 S/A FS-2
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12267608
• Report Number: 2210968-2021-06924
• Device Sequence Number: 5244746
• Product Code: NEW
• UDI-Device Identifier: 10705031060890
• UDI-Public: 10705031060890
• Combination Product (Y/N): N
• 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: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/08/2021

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: 10/31/2021
• Device Model Number: Z422H
• Device Catalogue Number: Z422H
• Device Lot Number: KM7628
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2021
• Initial Report FDA Received Date: 08/03/2021
• Patient Sequence Number: 1